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Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer Clinical research trials and Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer healthcare trials occur in a lot of of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer. Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer clinical trial. Test subjects typically receive the most effective healthcare possible for their Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer  Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
For Condition: adenocarcinoma of the stomach,Adenocarcinoma of the Esophagus,stage 3 gastric cancer,stage 3 esophageal cancer,stage 4 esophageal cancer,stage 4 gastric cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , M.D. Anderson Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining bryostatin1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.
Details: OBJECTIVES: I. Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel. II. Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients. PROTOCOL OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR. Patients are followed until death. PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction Measurable disease - At least 20 mm with conventional techniques OR - At least 10 mm with spiral CT scan - The following are not considered measurable: *Bone lesions *Leptomeningeal disease *Ascites *Pleural/pericardial effusion *Inflammatory breast disease *Lymphangitis cutis/pulmonis *Abdominal masses that are not confirmed or followed by imaging techniques *Cystic lesions No bone metastases as sole disease site No brain metastases --Prior/Concurrent Therapy-- Biologic therapy: - At least 6 months since prior adjuvant immunotherapy - No prior immunotherapy outside of the adjuvant setting - No concurrent immunotherapy Chemotherapy: - At least 6 months since prior adjuvant chemotherapy - No prior chemotherapy outside of the adjuvant setting - No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: - At least 4 weeks since prior radiotherapy - No prior radiotherapy to major bone marrow containing areas (pelvis, lumbar spine) or to study lesion - No concurrent radiotherapy Surgery: At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered Other: No concurrent anticoagulants --Patient Characteristics-- Age: 18 and over Performance status: - Zubrod 0-1 - Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: - Granulocyte count at least 1,500/mm3 - Hemoglobin at least 8 g/dL - Platelet count at least 100,000/mm3 - No bleeding diathesis Hepatic: - Bilirubin no greater than 1.5 mg/dL - Transaminases no greater than 2.5 times upper limit of normal Renal: - Creatinine no greater than 1.5 mg/dL - Calcium no greater than 12 mg/dL - No symptomatic hypercalcemia Cardiovascular: - No New York Heart Association class III or IV heart disease - No angina, myocardial infarction, or congestive heart failure in past 6 months Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No serious concurrent infections, nonmalignant medical illnesses, or psychiatric disorders that may preclude study - No other prior malignancy in past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JafferAjani, Study Chair, M.D. Anderson Cancer Center
University of Texas - MD Anderson Cancer Center
Houston, Texas, 77030-4009
United States
CCOP - M.D. Anderson Research Base
Houston, Texas, 77030-4009
United States
Additional Information:
Study ID Numbers: CDR0000068069; NCI-T99-0103,MDA-ID-99203
Study Start Date: March 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006081
Other Stage 3 Esophageal Cancer Studies:
1. Quality-of-Life Assessment of Patients Who Have Cancer of the Esophagus
2. Erlotinib in Treating Patients With Advanced Esophageal Cancer or Stomach Cancer
3. Flavopiridol and Paclitaxel in Treating Patients With Locally Advanced or Metastatic Esophageal Cancer That Has Not Responded to Previous Paclitaxel
4. Paclitaxel in Treating Patients With Metastatic, Recurrent, or Unresectable Cancer of the Esophagus
5. Edotecarin and Cisplatin in Treating Patients With Advanced or Metastatic Solid Tumors
Related Studies:
Other stage 3 esophageal cancer Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
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