Clinical Trials

Cancer Treatment Clinical Trials

Medical science continues to advance the frontiers of understanding and develop new and effective treatments for many medical conditions. In many cases, life-saving treatments that define the current standard of care today were unheard of a decade ago. Similarly, work taking place right now in research laboratories will make some of our current treatments obsolete, offering hope to patients who currently have few effective options.

Cancer treatment clinical trials give patients the opportunity to play a role in developing promising new therapies and in ensuring that these therapies become available to all patients in need. Without the benefit of the valuable information gained through clinical trials, medical research could not move forward as it does.

Participating in a clinical trial can aid you directly by giving you access to potentially helpful treatments before they are available to the general public. Your participation may mean that you are among the first to benefit from the latest cutting-edge research as it moves out of the laboratory and into doctors' hands.

Who can participate in a cancer treatment clinical trial?

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

What happens during a cancer treatment clinical trial?

The clinical trial process depends on the kind of trial being conducted (See Different types of clinical trials?) The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

The benefits and risks of participating in a clinical trial?

Benefits

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:

• Play an active role in their health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

Risks

There are risks to clinical trials.

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including trips to the study site, more treatments, hospital stays or complex dosage requirements.

Side effects and Adverse Reactions

Side effects are any undesired actions or effects of the experimental drug or treatment. Negative or adverse effects may include headache, nausea, hair loss, skin irritation, or other physical problems. Experimental treatments must be evaluated for both immediate and long-term side effects.

Different types of cancer treatment clinical trials?

• Treatment. These trials test the effectiveness of new treatments or new ways of using current treatments in people who have cancer. The treatments tested may include new drugs or new combinations of currently used drugs, new surgery or radiation therapy techniques, and vaccines or other treatments that stimulate a person’s immune system to fight cancer. Combinations of different treatment types may also be tested in these trials.

• Prevention. These trials test new interventions that may lower the risk of developing certain types of cancer. Most cancer prevention trials involve healthy people who have not had cancer; however, they often only include people who have a higher than average risk of developing a specific type of cancer. Some cancer prevention trials involve people who have had cancer in the past; these trials test interventions that may help prevent the return (recurrence) of the original cancer or reduce the chance of developing a new type of cancer

• Screening. These trials test new ways of finding cancer early. When cancer is found early, it may be easier to treat and there may be a better chance of long-term survival. Cancer screening trials usually involve people who do not have any signs or symptoms of cancer. However, participation in these trials is often limited to people who have a higher than average risk of developing a certain type of cancer because they have a family history of that type of cancer or they have a history of exposure to cancer-causing substances (e.g., cigarette smoke).

• Diagnostic. These trials study new tests or procedures that may help identify, or diagnose, cancer more accurately. Diagnostic trials usually involve people who have some signs or symptoms of cancer.

• Quality of life or supportive care. These trials focus on the comfort and quality of life of cancer patients and cancer survivors. New ways to decrease the number or severity of side effects of cancer or its treatment are often studied in these trials. How a specific type of cancer or its treatment affects a person’s everyday life may also be studied.

Cancer Treatment Clinical Trial Phases

The testing of new treatments in clinical trials is divided into four phases:

Phase I trials help researchers determine the most appropriate dosage and to identify any side effects that may be associated with the new treatment. This phase also helps determine the best way to deliver the new treatment – for example if a drug should be given by injection or by mouth. Phase I trials typically involve fewer than 100 participants.

Phase II trials test the treatment in patients who have the targeted medical condition in order to begin determining its effectiveness. Researchers continue to track the drug's safety and side effects. Phase II trials involve more patients, but are still very limited in size.

Phase III trials compare the new treatment to one or more standard therapies currently in use among patients. The new treatment is sometimes combined with established therapies to determine if the combination is more effective than standard therapy alone. Safety and side effects continue to be tracked as the study expands to include hundreds or even thousands of patients.

Phase IV trials can begin once the treatment is approved for general use to continue to monitor its safety and effectiveness and to give researchers and physicians additional information about how best to employ the new treatment.

The Role of the FDA

The Food and Drug Administration (FDA) is the federal agency responsible for making sure that new drugs and medical devices are safe and effective. No treatment is risk-free, but it is the FDA's role to judge whether a new treatment's benefits to the patient outweigh its risks. They oversee every phase of a clinical trial and decide if the evidence supports continued testing and, eventually, approval for doctors to prescribe the new treatment in this country.

Informed Consent

The informed consent process provides patients the information they need in order to make an educated decision to begin or continue to participate in a clinical trial. The research team will discuss with you the trial's purpose, procedures, risks and potential benefits, and your rights as a participant. The team will also provide a document that includes all this information for your reference throughout the study and will continue to provide information to you during your participation in the trial. Your signature on the informed consent document gives your official consent to participate in the study, but you always retain the right to leave the study at any time for any reason.

Who Sponsors Clinical Trials?

The sponsor can be the pharmaceutical company, research institution, or health organization that funds a clinical trial. This funding source can be a commercial enterprise, a governmental agency, or a philanthropic organization.

Cost of Participation

The research costs associated with a clinical trial, including data collection and analysis, health care professionals who work on the research project, and tests performed for research purposes are paid by the research sponsor.

Other costs for medical goods and services, including doctors' professional fees, hospital stays, laboratory tests, and medical imaging made necessary by your medical condition independent of your participation in the clinical trial, are often not covered by the research sponsor. Third-party health insurance may pay for some or all of these costs, but their obligation to do so varies among insurance plans. Be aware that health care delivered in the context of a clinical trial will most often be considered "investigational." Investigational therapies are often excluded from coverage under medical plans. You should discuss the financial aspects of your participation in a clinical trial with both your physician and with a representative of your insurance plan.

What should people consider before participating in a trial?

People should know as much as possible about the clinical trial and feel comfortable asking the members of the health care team questions about it, the care expected while in a trial, and the cost of the trial. The following questions might be helpful for the participant to discuss with the health care team. Some of the answers to these questions are found in the informed consent document.

What is the purpose of the study?
How long will I be in the study?
How many people will participate in the study?
In which phase of the study will I participate?
How often will I need to go to the hospital or clinic?
What tests will I need?
Will my medical records remain confidential?
Is there a chance that I will receive a placebo in the study?
Will I continue to see my own personal doctor?
Will there be any cost to me?
Will participating in the study affect my daily life?
What kind of long-term follow-up care is included in the study?
Will I learn the results of the study? If so, when?
What are the potential benefits and possible risks?

Breast:

• Observational study of treatment pattern:     An Observational Study of Treatment Patterns of Safety Outcomes of metastatic or Locally Advanced Breast CA.
• Phase II study evaluating Trastuzumab:     Phase II Randomized Trial of Neoadjuvant Trastuzumab and/or Lapatinib plus Chemotherapy (Sequential FEC75 and Paclitaxel) in Women
• Phase III study evaluating Neratinib:     A Phase 3, Randomized, Open-Label Study of Neratinib Versus Lapatinib Plus Capecitabine for the Treatment of ErbB-2-Positive Locally Advanced or Metastatic Breast Cancer
• Phase III trial evaluating Pertuzumab:     Trastuzumab in combination with DocetaxelA Phase III Randomized, Double-Blind, and Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated Her2-Positive Metastatic Breast Cancer.
• Phase III Bevacizumab Trial:     An International, Multi-Center, Open - Label, Two Arm, Phase III Trial of Adjuvant bevacizumab in “Triple Negative” Breast Cancer
• Phase III study evaluating Trastuzumab:     A Randomized, Multicenter, Phase III Open-Label Study of the Efficacy and Safety of Trastuzumab-MCC-DM1 VS. Capecitabine and Lapatinib in Patients with HER2-Positive Locally Advanced or Metastatic Breast Cancer who have Received Prior Trastuzumab-Based Therapy
• Trial evaluating Bosutinib with Letrozole vs. Letrozole alone:     A Phase II, Randomized, Open-label Study of Bosutinib Administered in Combination With Letrozole Versus Letrozole Alone as First Line Therapy in Post-Menopausal Women With Locally Advanced or Metastatic ER+/PgR+/erbB2- Breast Cancer.
• Trial evaluating YM155 - A Phase II, Multicenter, Open-Label, Randomized Study of YM155 Plus Docetaxel as First-Line Treatment in Subjects with HER2 Negative Metastatic Breast Cancer Protocol for Phase II Study of YM155
• Trial evaluating Lapatinib or Trastuzumab - A Randomized, open-label, phase III study of Taxane based chemotherapy with Lapatinib or Trastuzumab as first Line therapy for women with HER2/neu positive metastatic breast cancer.
• Trial evaluating T-DM1 - A randomized, 3 arm, multicentre, phase III study to evaluate the efficacy and the safety of T-DM1 combined with pertuzumab or T-DM1 combined with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab plus taxane, as first line treatment in HER2- positive progressive or recurrent locally advanced or metastatic breast cancer (MBC).
• Trial evaluating Exemestane plus GnRH -  A Phase III Trial Evaluating the Role of Exemestane Plus GnRH Analogue as Adjuvant Therapy for Premenopausal Women with Endocrine Responsive Breast Cancer.
• Trial evaluating KW-2450 - A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of KW-2450 in Combination with Lapatinib and Letrozole in Subjects with Advanced or Metastatic Breast Cancer whose Tumors Overexpress HER2
• Observational study - An observational cohort study of treatment patterns and outcomes in patients with HER2 positive (HER2+) Metastatic Breast Cancer
• Trial evaluating Capecitaien vs Lapatinib:  A study of Neratinib plus Capecitabine versus Lapatinib Plus Capecitabine in patients with HER2+ with HER2+ metastatic Breast Cancer who have received two or more prior HER2-Directed regimens in the metastatic setting (NALA) - 

Chronic Lymphocytic Leukemia:

• *Phase III study evaluating Revlimid vs Chloramubcil:  A Phase 3, Multicenter, Randomized, Open-Label, Parallel-Group Study of the Efficacy and Safety of Lenalidomide (Revlimid®) versus Chlorambucil as First-Line Therapy for Previously Untreated Elderly Patients with B-Cell Chronic Lymphocytic Leukemia.

Colorectal:

• *Phase II study evaluating NKTR-102:     A Multicenter, Open-Label, Randomized, Phase II Study to Evaluate the Efficacy and Safety of NKTR-102 (PEG-Irinotecan) Versus Irinotecan in Patients with Second-Line, Irinotecan-Naïve, KRAS-Mutant, Metastatic Colorectal Cancer (mCRC).
• Trial evaluating FOLFOX plus Celecoxib: A Phase III Trial of 6 versus 12 Treatments of Adjuvant FOLFOX Plus Celecoxib or Placebo for Patients with Resected Stage III Colon.
• *Phase III study evaluating Imprime PGG and Erbitux: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination with Cetuximab (Erbitux®) in Subjects with Recurrent or Progressive KRAS Wild Type Colorectal Cancer
• Trial evaluating PGG: A Phase 3 Open-Label, Randomized, Multicenter Study of Imprime PGG® in Combination with Cetuximab (Erbitux®) in Subjects with Recurrent or Progressive KRAS Wild Type Colorectal Cancer

Gastrointestinal:

• An Observational trial for patients with GIST:     An Observational Database to Obtain Data on Variations in Current Diagnostic and Therapeutic Management of Patients with GIST in a Variety of Practice Setting.
• Trial evaluating trastuzumab: A randomized, open-label, multicenter Phase IIIb study comparing two trastuzumab dosing regimens, each in combination with cisplatin/capecitabine chemotherapy, as first-line therapy in patients with HER2-positive metastatic gastric or gastro-esophageal junction adenocarcinoma who have not received prior treatment for metastatic disease.

Head and Neck:

• *rial evaluating Cetuximab:    A Randomized, Double-Blind, Phase 2 Safety Study of Cetuximab, Using ImClone versus  Boehringer Ingelheim Manufacturing Processes, in Combination with Cisplatin or Carboplatin and 5-Fluorouracil in the First-Line Treatment of Patients with Locoregionally Recurrentand/or Metastatic Squamous Cell Carcinoma of the Head and Neck.

Hepatocellular:

• Trial evaluating Nexavar:     Phase IV non-interventional study of Nexavar in Hepatocellular carcinoma.
• Trial evaluating Brivanib vs Sorafenib:     A Randomized, Double-blind, Multi-center Phase III Study of Brivanib versus Sorafenib as First-line Treatment in Patients with Advanced Hepatocellular Carcinoma.

ITP:

• Trial evaluating IGIV3I:     A Multi-Center, Prospective, Open-Label, Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin (IGIV3I Grifols 10%) in Patients with Idiopathic (Immune) Thrombocytopenic Purpura.

Lung:

• An observational trial evaluating Pemetrexed:     An observational study evaluating the impact of ethnic origin on patients being treated second line with pemetrexed in Non-small Cell Lung Cancer.
• Trial evaluating the long-term safety of Darbepoetin Alfa:     A Randomized, Double-blind, Placebo-controlled Study to evaluate the long-term safety and efficacy of Darbepoetin Alfa administered at 500mg Once every 3 weeks (Q3W) in Anemic Subjects with Advance Stage Non-small Cell Lung Cancer receiving Multiple-cycle chemotherapy.
• Trial evaluating Paclitaxel Poliglumex/Carboplatin vs. Paclitaxel/Carboplatin:     Paclitaxel Poliglumex (CT-2103)/Carboplatin vs. Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell lung Cancer (NSCLC) in Women with Estradiol >30 pg/mL
• Phase II study evaluating PF-00299804:     Phase II, open label, trial of PF-00299804 in untreated advanced adenocarcinoma of the lung in never or former light smokers.
• Phase II trial evaluating Maintenance Temozolomide:     A Randomized Phase II Study of Maintenance Temozolomide Versus Observation in Stable or Responding Stage IIIB/IV Non-Small Cell Lung Cancer Patients.
• Phase III study evaluating BIBF:     Multicenter, randomized, double-blind, Phase III trial to investigate the efficacy and safety of oral BIBF 1120 plus standard pemetrexed therapy compared to placebo plus standard pemetrexed in patients with stage IIIB/IV or recurrent non-small cell lung cancer after failure of first line chemotherapy
• Phase III vaccine trial evaluating Stimuvax:     Phase III randomized, double-blind placebo-controlled study of the Cancer Vaccine “Stimuvax (L-BLP25 or BLP25 liposome vaccine) in NSCLC Subjects with unresectable stage III disease” or START Trial.
• Trial evaluating Bavituximab -  A Randomized, Open-Label, Phase 2 Trial of Paclitaxel/Carboplatin With or Without Bavituximab in Patients with Previously Untreated Locally Advanced or Metastatic Non-Squamous Non-Small-Cell Lung Cancer.
• Trial evaluating BIBW 2992 - LUX - Lung 3, A Randomized, Open-Label, Phase III Study of BIBW 2992 versus Chemotherapy as First-line Treatment for Patients with Stage IIIB or IV Adenocarcinoma of the Lung Harbouring an EGFR Activating Mutation.
• Trial evaluating Darbepoetin Alfa -  A Randomized, Double-blind, Placebo-controlled Study to evaluate the long-term safety and efficacy of Darbepoetin Alfa administered at 500mg Once every 3 weeks (Q3W) in Anemic Subjects with Advance Stage Non-small Cell Lung Cancer receiving Multiple-cycle chemotherapy.
• Trial Evaluating Bavituximab and Docetaxel - A Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial of Bavituximab Plus Docetaxel in Patients with Previously Treated Locally Advanced or Metastatic Non-Squamous.
• *Trial Evaluating Bavituximab and Docetaxel - Phase 2, Double-Blind, Placebo-Controlled Study of IPI-504 and Docetaxel in Previously Treated Patients with Stage IIIB or IV Non-Small Cell Lung Cancer.
• A Study of HSP90 Inhibitor AT13387 Alone and in Combination with Crizotinib in the Treatment of Non-small Cell Lung Cancer (NSCLC)
• Trial Evaluating Lenvatinib:  A Multicenter, Open-Label Phase 2 Study of the Safety and Activity of Lenvatinib (E7080) in Subjects With KIF5B-RET-Positive Adenocarcinoma of the Lung.
• Trial Evaluating MO22097:  An Open-Label, Randomized, Phase IIIb Trial Evaluating the Efficacy and Safety of Standard of Care +/- Continuous Bevacizumab Treatment Beyond Progression of Disease in Patients with Advanced Non-Squamous Non-Small Cell Lung Cancer (NSCLC) After First-Line Treatment with Bevacizumab Plus A Platinum Douublet-containing Chemotherapy (MO22097)

Multiple Myeloma:

• Trial evaluating role of Zoledronic Acid:     Bone Marker directed dosing of Zometa (Zoledronic acid) for the prevention of skeletal complications in patients with advanced multiple myeloma.
• A Phase II study of DVD:     A Phase II Study of Pegylated Liposomal Doxorubicin, Bortezomib and Dexamethason (DVD) for patients and Newly Diagnosed Multiple Myeloma.
• Phase IIIb study evaluating Velcade:     Randomized Phase IIIb Study of Three Treatment Regimens in Subjects with Previously Untreated Multiple Myeloma Who Are Not Considered Candidates for High-Dose Chemotherapy and Autologous Stem Cell Transplantation: VELCADE (Bortezomib), Thalidomide, and Dexamethasone (VTD) versus VELCADE and Dexamethasone (VD) versus VELCADE, Melphalan, and Prednisone (VMP).

Ovarian:

• Trial evaluating TXA127:    Phase IIb Study Evaluating the Safety and Efficacy of TXA127 in the Reduction of Incidence and Severity of Thrombocytopenia in Patients Receiving Combination Gemcitabine and Platinum Therapy for Ovarian, Fallopian Tube or Peritoneal Carcinoma
• *Trial evaluating Cvac: A Randomized, Double-Blinded, Placebo-Controlled Trial of Cvac (Augologous Dendritic Cells Pulsed with Recombinant Human Fusion Protein [Mucin 1-Glutathione S-Transferqase] Coupled to Oxidized Polymannose) as Maintenance Treatment in Patients with Epithelial Ovarian Cancer (EOC) IN Complete Remission Following Dirst-Line Chemotherapy

Pancreatic:

•  

  *Trial evaluating Gemcitabine and Bavituximab:     A Randomized, Open-Label, Phase 2 Trial of Gemcitabine With or Without Bavituximab in Patients with Previously Untreated Stage IV Pancreatic Cancer.
•  Trial evaluating KLT - A Randomized Safety and Exploratory Efficacy Study of Kanglaite injection Plus Gemcitabine (G+K) versus Gemcitabine in patients with advancedpancreatic cancer.

Prostate:

• Trial evaluating Zoledronic Acid :     A randomized, Double-Blind, Placebo-Controlled Phase III Study of Early versus Standard Zoledronic Acid to prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone.
• *Trial evaluation OGX-011-11:  A Randomized Phase III Study Comparing Standard First-Line Docetaxel/Prednisone to Docetaxel/Prednisone in Combination with Custirsen (OGX-011) in Men with Metastatic Castrate-Resistant Prostate Cancer

Renal Cell Carcinoma:

• Trial evaluating Pazopanib vs. Sunitinib:     A Study of Pazopanib vs. Sunitinib in the Treatment of Subjects with Locally Advanced and/or Metastatic Renal Cell Carcinoma.
• Trial evaluating Axitinib:     Axitinib (AG-013736) as Second Line Therapy for Metastatic Renal Cell Cancer.

Solid Tumors:

• Trial evaluating corrected QT interval and drug:  A Phase Ib, Single-Arm, Open-Label Clinical Trial to Evaluate Corrected QT Interval and Drug-- Drug Interaction of Trastuzumab on Carboplatin in the Presence of Docetaxel in Patients with HER2-Positive Metastatic or Locally Advanced Inoperable Cancer

Sarcoma:

• Pivotal trial evaluating the role of AP23573A:     Pivotal trial to determine the efficacy and safety of AP23573 when administered as maintenance therapy to patients with metastatic soft tissue or bone sarcomas. Documented histologic diagnosis of soft-tissue or bone sarcoma that has metastasized, with the exception of certain histopathologic subtypes of sarcomas recognized by experts to derive no benefit from conventional chemotherapies or with distinctly different natural histories. See protocol for a list of excluded sarcoma subtypes. Patients with PR or SD at study entry must have least one measurable or evaluable lesion as defined by RECIST guidelines. Patients with metastatic bone sarcoma must have at least one measurable visceral lesion or have achieved a CR of visceral metastasis.

 * current open trials