Gastric Cancer Clinical Trial
Official title:
A Phase II Trial of CPT-11 in Patients With Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction Incorporating Pretreatment and Posttreatment Biopsies for Evaluation of Tumor Thymidylate Synthase, MIB-1, Topoisomerase I, and p53
Verified date | July 2016 |
Source | Alliance for Clinical Trials in Oncology |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of irinotecan in treating patients who
have advanced cancer of the stomach.
Status | Completed |
Enrollment | 70 |
Est. completion date | July 2004 |
Est. primary completion date | July 2004 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
DISEASE CHARACTERISTICS: Histologically confirmed advanced adenocarcinoma of the stomach
or gastroesophageal junction beyond hope of surgical cure and not considered a candidate
for potentially curative chemotherapy/radiation therapy Measurable or evaluable disease
Tumor must be accessible for biopsy No known central nervous system metastases or
carcinomatous meningitis PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hemoglobin at least 9.0 mg/dL (transfusion allowed) Hepatic: Bilirubin no greater than upper limit of normal (ULN), regardless of liver involvement secondary to tumor AST no greater than 3 times ULN Renal: Creatinine no greater than 1.5 times ULN Cardiovascular: No unstable angina No uncontrolled high blood pressure No active congestive heart failure No myocardial infarction in the last 6 months No serious uncontrolled cardiac arrhythmia No New York Heart Association Class III or IV heart disease Pulmonary: No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung No pleural effusion or ascites, which cause respiratory compromise (at least Grade 2 dyspnea) Other: No active or uncontrolled infection No prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, adequately treated noninvasive carcinomas, or other cancer from which the patient has been disease free for at least 5 years Not pregnant or nursing Adequate contraception required of all fertile patients PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for gastric or gastroesophageal junction cancer No prior irinotecan (CPT-11) or other camptothecin Endocrine therapy: Not specified Radiotherapy: No prior abdominal or pelvic radiotherapy No prior radiotherapy to greater than 25% of bone marrow No prior radiotherapy to measurable or evaluable indicator lesions At least 4 weeks since major radiotherapy (chest radiotherapy) Surgery: At least 3 weeks since major surgery and recovered At least 2 weeks since minor surgery and recovered Other: No other concurrent investigational agents |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | Allan Blair Cancer Centre | Regina | Saskatchewan |
United States | Medcenter One Health System | Bismarck | North Dakota |
United States | CCOP - Cedar Rapids Oncology Project | Cedar Rapids | Iowa |
United States | CCOP - Geisinger Clinic and Medical Center | Danville | Pennsylvania |
United States | CCOP - Iowa Oncology Research Association | Des Moines | Iowa |
United States | CCOP - Duluth | Duluth | Minnesota |
United States | CCOP - Merit Care Hospital | Fargo | North Dakota |
United States | Altru Health Systems | Grand Forks | North Dakota |
United States | Mayo Clinic Jacksonville | Jacksonville | Florida |
United States | CCOP - Missouri Valley Cancer Consortium | Omaha | Nebraska |
United States | CCOP - Illinois Oncology Research Association | Peoria | Illinois |
United States | Rapid City Regional Hospital | Rapid City | South Dakota |
United States | Mayo Clinic Cancer Center | Rochester | Minnesota |
United States | CentraCare Clinic | Saint Cloud | Minnesota |
United States | CCOP - Scottsdale Oncology Program | Scottsdale | Arizona |
United States | Siouxland Hematology-Oncology | Sioux City | Iowa |
United States | CCOP - Sioux Community Cancer Consortium | Sioux Falls | South Dakota |
United States | CCOP - Carle Cancer Center | Urbana | Illinois |
United States | CCOP - Wichita | Wichita | Kansas |
Lead Sponsor | Collaborator |
---|---|
Alliance for Clinical Trials in Oncology | National Cancer Institute (NCI) |
United States, Canada,
Erlichman C, Goldberg RM, Mahoney MR, et al.: A phase II trial of CPT-11 in patients (pts) with advanced gastric or gastroesophageal (GE) junction adenocarcinoma (ADCA): a clinical and pharmacodynamic evaluation. A North Central Cancer Treatment Group (NC
Jatoi A, Foster NR, Egner JR, Burch PA, Stella PJ, Rubin J, Dakhil SR, Sargent DJ, Murphy BR, Alberts SR. Older versus younger patients with metastatic adenocarcinoma of the esophagus, gastroesophageal junction, and stomach: a pooled analysis of eight consecutive North Central Cancer Treatment Group (NCCTG) trials. Int J Oncol. 2010 Mar;36(3):601-6. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | response rate | Up to 3 years | No | |
Secondary | survival | Up to 3 years | No |
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