Gemox as First and Second Line Therapy in Unknown Primary Cancer
- To determine the overall tumor response rate with oxaliplatin in combination with gemcitabine (GEMOX) as first line and second line therapy in unknown primary cancer (UPC).
- To determine the tolerability (toxicity) of this regimen in this patient population.
- To determine the median overall survival (OS) and time to progression (TTP) for patients treated with this combination.
- To determine the impact of this combination on quality of life (QOL) in this patient population.
Unknown Primary Neoplasms
Drug: Gemcitabine (Gemox)
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study to Evaluate the Efficacy and Toxicity of Oxaliplatin in Combination With Gemcitabine as First and Second Line Therapy in Unknown Primary Cancer|
- Participants' Response [ Time Frame: Response to treatment measured using Response Evaluation Criteria in Solid Tumors (RECIST) criteria with radiological evaluation at 6 weeks and reevaluated every 6 weeks. ] [ Designated as safety issue: Yes ]Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): At least 30% decrease in sum of longest diameter (LD) of target lesions, reference baseline sum LD; Progressive Disease (PD): At least 20% increase in sum of LD of target lesions, reference smallest sum LD recorded since treatment started or appearance of 1 or more new lesions; Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor increase to qualify for PD, reference smallest sum LD since treatment started.
|Study Start Date:||February 2004|
|Study Completion Date:||January 2010|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
Experimental: Gemcitabine + Oxaliplatin
Gemcitabine 1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 and Oxaliplatin 100 mg/m^2 by vein infused on Day 2 over two hours. Repeated every 14 days (one cycle).
Drug: Gemcitabine (Gemox)
1000 mg/m^2, infused at 10 mg/m^2/min on Day 1 repeated every 14 days (one cycle).
Other Names:Drug: Oxaliplatin
100 mg/m^2 by vein infused on Day 2 over two hours, repeated every 14 days (one cycle).
Other Name: EloxatinBehavioral: Questionnaire
Quality of Life Surveys
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Oxaliplatin is a chemotherapy drug that causes the death of cancer cells and other actively dividing cells by interfering with Deoxyribonucleic acid (DNA) function. Gemcitabine prevents cells from making DNA and Ribonucleic acid (RNA) that are necessary for cell growth, thus disrupting the growth of the cancer cells, which causes the cancer cells to start to die.
After the screening portion of the study, if you are eligible to begin study treatment, you will come to M. D. Anderson at least every two weeks (14 days) for treatment. Each 14-day period of treatment is called a "cycle" of therapy. You will receive at least 3 cycles of therapy (6 weeks) unless side effects become intolerable or the disease progresses.
When you begin treatment, you will have a small tube (central venous line) inserted into a large vein under the skin of the chest or through a vein in the arm for administration of oxaliplatin and gemcitabine. The central venous line will remain in place the entire time you are taking part in this study. Both drugs must be given at M. D. Anderson. On Day 1 of each cycle, you will receive gemcitabine injected into a vein over 2 hours. On Day 2 of each cycle you will receive oxaliplatin injected into a vein over 2 hours. This drug schedule will be repeated every 2 weeks.
You will first be asked to fill out several questionnaires that deal with your quality of life. These will help the researchers understand how the study drugs affect your quality of life including your pain level, fatigue (tiredness) level, appetite, and ability to perform everyday tasks, in spite of whether there is any shrinkage of the tumor. It will take about 30 minutes to an hour to complete the forms. You will also be asked to complete a questionnaire (one time only) that asks questions about why you decided to take part in this study.
During the first cycle of therapy, blood (about 2 1/2 teaspoons) will be collected once a week for routine tests. Before each new cycle of therapy, you will have a complete physical exam, urine will be collected, and blood will be drawn (about 2 ½ teaspoons) for routine tests. You will be asked to tell the study doctor about all medications you have taken since you started taking the study drugs and any health problems that you may have experienced. You will also have either computed tomography (CT) scans or an Magnetic resonance imaging (MRI) of the tumor(s) every 6 weeks and at the end of the study.
All tests before each new cycle of treatment and when treatment stops must be done at M. D. Anderson. Extra tests may be done during the study if your doctor feels it is necessary for your care. Every 6 weeks for as long as you are on study, you will also be asked to fill out the questionnaires that help study doctors understand your quality of life. It will take about 30 minutes to an hour to complete the forms.
If you experience intolerable side effects, treatment may be delayed, stopped, or you may receive smaller doses of the treatment. You may continue to receive treatment on this study, unless the disease gets worse or you experience any intolerable side effects. If this happens, you will be taken off the study and your doctor will discuss other treatment options with you.
When you stop taking part in the study for any reason, you will have blood (about 3 teaspoons) collected for final routine tests. You will have one more physical exam and either a CT scan or a MRI to check on the status of the disease. You will also be asked once more to fill out the questionnaires that help assess your quality of life. It will take about 30 minutes to an hour to complete the forms.
Once you stop receiving study treatment, you will be contacted by phone every three months for the rest of your life to check on how you are doing and any symptoms you may be experiencing.
This is an investigational study. Oxaliplatin is FDA approved for treatment of advanced cancer of the colon or rectum, and gemcitabine is FDA approved for the treatment of advanced cancer of the pancreas. However, the combination of the two drugs for treatment of cancers with unknown primaries is still considered investigational. Up to 81 people will take part in this study. All will be enrolled at M. D. Anderson.
|United States, Texas|
|U.T. M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Gauri R. Varadhachary, MD||M.D. Anderson Cancer Center|