Dolastatin 10 in Treating Patients With Metastatic Or Recurrent Liver, Bile Duct, or Gallbladder Cancer
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Purpose
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 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: 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 |
- Objective Response Rate [ Time Frame: 2 years ] [ Designated as safety issue: No ]
| Enrollment: | 16 |
| Study Start Date: | January 1999 |
| Study Completion Date: | August 2003 |
| Primary Completion Date: | June 2000 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm A
Dolastatin-10 (400 mcg/m2 IV every 3 weeks)
|
Drug: dolastatin 10 |
Detailed Description:
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.
Eligibility| 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
Contacts and Locations| United States, Illinois | |
| University of Illinois at Chicago | |
| Chicago, Illinois, United States, 60612 | |
| University of Chicago Cancer Research Center | |
| Chicago, Illinois, United States, 60637 | |
| Louis A. Weiss Memorial Hospital | |
| Chicago, Illinois, United States, 60640 | |
| Cancer Care Specialists of Central Illinois, S.C. | |
| Decatur, Illinois, United States, 62526 | |
| Evanston Northwestern Health Care | |
| Evanston, Illinois, United States, 60201 | |
| Lutheran General Cancer Care Center | |
| Park Ridge, Illinois, United States, 60068 | |
| Illinois Oncology Research Association | |
| Peoria, Illinois, United States, 61602 | |
| Central Illinois Hematology Oncology Center | |
| Springfield, Illinois, United States, 62701 | |
| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Hedy Kindler, MD, Associate Professor, University of Chicago |
| ClinicalTrials.gov Identifier: | NCT00003557 History of Changes |
| Other Study ID Numbers: | 9409, UCCRC-9409, NCI-T98-0010 |
| Study First Received: | November 1, 1999 |
| Last Updated: | February 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Chicago:
|
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 |
Additional relevant MeSH terms:
|
Liver Neoplasms Gallbladder Neoplasms Bile Duct Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Liver Diseases Biliary Tract Neoplasms Biliary Tract Diseases |
Gallbladder Diseases Bile Duct Diseases Dolastatin 10 Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013