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Sponsors and Collaborators: |
University of Chicago National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003557 |
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.
Condition | Intervention | Phase |
---|---|---|
Extrahepatic Bile Duct Cancer Gallbladder Cancer Liver Cancer |
Drug: dolastatin 10 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | A Phase II Trial of Dolastatin-10 (NSC 376128) Administered as an IV Bolus Every 3 Weeks in Patients With Hepatobiliary Cancer |
Estimated Enrollment: | 35 |
Study Start Date: | January 1999 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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
United States, Illinois | |
Cancer Care Specialists of Central Illinois, S.C. | |
Decatur, Illinois, United States, 62526 | |
Central Illinois Hematology Oncology Center | |
Springfield, Illinois, United States, 62701 | |
Evanston Northwestern Health Care | |
Evanston, Illinois, United States, 60201 | |
Illinois Oncology Research Association | |
Peoria, Illinois, United States, 61602 | |
Louis A. Weiss Memorial Hospital | |
Chicago, Illinois, United States, 60640 | |
Lutheran General Cancer Care Center | |
Park Ridge, Illinois, United States, 60068 | |
University of Chicago Cancer Research Center | |
Chicago, Illinois, United States, 60637 | |
University of Illinois at Chicago | |
Chicago, Illinois, United States, 60612 | |
United States, Indiana | |
Fort Wayne Medical Oncology and Hematology, Inc. | |
Fort Wayne, Indiana, United States, 46885-5099 | |
Michiana Hematology/Oncology P.C. | |
South Bend, Indiana, United States, 46617 | |
United States, Texas | |
University of Texas - MD Anderson Cancer Center | |
Houston, Texas, United States, 77030 |
Study Chair: | Hedy L. Kindler, MD | University of Chicago |
Study ID Numbers: | CDR0000066620, UCCRC-9409, NCI-T98-0010 |
Study First Received: | November 1, 1999 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00003557 History of Changes |
Health Authority: | United States: Federal Government |
advanced adult primary liver cancer recurrent adult primary liver cancer unresectable gallbladder cancer recurrent gallbladder cancer |
unresectable extrahepatic bile duct cancer recurrent extrahepatic bile duct cancer adult primary hepatocellular carcinoma cholangiocarcinoma of the gallbladder |
Gallbladder Diseases Cholangiocarcinoma Liver Diseases Biliary Tract Neoplasms Digestive System Neoplasms Carcinoma, Hepatocellular Antimitotic Agents Bile Duct Cancer, Extrahepatic Recurrence Carcinoma Liver Neoplasms |
Gall Bladder Cancer Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases Tubulin Modulators Gastrointestinal Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Hepatocellular Carcinoma Dolastatin 10 |
Gallbladder Diseases Liver Diseases Biliary Tract Neoplasms Digestive System Neoplasms Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Antimitotic Agents Pharmacologic Actions Liver Neoplasms |
Neoplasms Neoplasms by Site Digestive System Diseases Bile Duct Diseases Therapeutic Uses Biliary Tract Diseases Tubulin Modulators Gallbladder Neoplasms Bile Duct Neoplasms Dolastatin 10 |