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| ID | Type | Description | Link |
|---|---|---|---|
| UCCRC-9409 | |||
| NCI-T98-0010 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 dolastatin 10 in treating patients with metastatic or recurrent liver, bile duct, or gallbladder cancer.
OBJECTIVES: I. Determine the objective response rate, time to progression, and survival of patients with previously untreated advanced hepatobiliary cancer treated with dolastatin 10. II. Determine the toxicity of this regimen in this patient population.
OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus every 3 weeks. Treatment continues for a minimum of 2 courses in the absence of unacceptable toxicity or disease progression. Patients are followed until death.
PROJECTED ACCRUAL: A total of 14-35 evaluable patients will be accrued for this study within 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A | Experimental | Dolastatin-10 (400 mcg/m2 IV every 3 weeks) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dolastatin 10 | Drug |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate | 2 years |
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DISEASE CHARACTERISTICS: Histologically confirmed metastatic, locally advanced, or recurrent cancer of the liver (hepatoma), bile duct, or gallbladder (cholangiocarcinoma) Bidimensionally measurable disease The following are not considered measurable lesions: Lesions seen on colonoscopic examination or barium studies Bone metastases CNS lesions CEA, CA19-9, or AFP levels Ascites No CNS disease only No symptomatic brain metastases
PATIENT CHARACTERISTICS: Age: 18 and over Performance status: CALGB 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,500/mm3 Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 OR Platelet count at least 75,000/mm3 in patients with clinically documented sequestration or hemodilution unrelated to primary bone marrow insufficiency Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 mg/dL Transaminases no greater than 5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No significant underlying medical or psychiatric illness No active infections No other malignancy within the past 5 years except curatively treated nonmelanoma skin cancer and carcinoma in situ of the cervix
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy for advanced or metastatic hepatobiliary cancer No other concurrent chemotherapy No concurrent investigational antineoplastic drugs Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to only site of measurable disease At least 6 weeks since prior radiotherapy and recovered No concurrent radiotherapy to any lesion Surgery: Not specified
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| Name | Affiliation | Role |
|---|---|---|
| Hedy L. Kindler, MD | University of Chicago | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Illinois at Chicago | Chicago | Illinois | 60612 | United States | ||
| University of Chicago Cancer Research Center |
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| Chicago |
| Illinois |
| 60637 |
| United States |
| Louis A. Weiss Memorial Hospital | Chicago | Illinois | 60640 | United States |
| Cancer Care Specialists of Central Illinois, S.C. | Decatur | Illinois | 62526 | United States |
| Evanston Northwestern Health Care | Evanston | Illinois | 60201 | United States |
| Lutheran General Cancer Care Center | Park Ridge | Illinois | 60068 | United States |
| Illinois Oncology Research Association | Peoria | Illinois | 61602 | United States |
| Central Illinois Hematology Oncology Center | Springfield | Illinois | 62701 | United States |
| Fort Wayne Medical Oncology and Hematology, Inc. | Fort Wayne | Indiana | 46885-5099 | United States |
| Michiana Hematology/Oncology P.C. | South Bend | Indiana | 46617 | United States |
| University of Texas - MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| ID | Term |
|---|---|
| D001650 | Bile Duct Neoplasms |
| D005706 | Gallbladder Neoplasms |
| D008113 | Liver Neoplasms |
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
| D008107 | Liver Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| C064570 | dolastatin 10 |
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