Completed

A Phase II Trial of Dolastatin-10 (NSC 376128) Administered as an IV Bolus Every 3 Weeks in Patients With Hepatobiliary Cancer

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What is being tested

dolastatin 10

Drug
Who is being recruted

Adenocarcinoma+14

+ Bile Duct Diseases

+ Biliary Tract Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: January 1999
See protocol details

Summary

Principal SponsorUniversity of Chicago
Last updated: March 6, 2014
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 1999

Actual date on which the first participant was enrolled.

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.

NCT00003557
Principal SponsorUniversity of Chicago
Last updated: March 6, 2014
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

16 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AdenocarcinomaBile Duct DiseasesBiliary Tract DiseasesBiliary Tract NeoplasmsCarcinomaDigestive System DiseasesDigestive System NeoplasmsGallbladder DiseasesLiver DiseasesNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialBile Duct NeoplasmsGallbladder NeoplasmsCarcinoma, HepatocellularLiver Neoplasms

Criteria

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Dolastatin-10 (400 mcg/m2 IV every 3 weeks)

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 11 locations

University of Illinois at Chicago

Chicago, United StatesOpen University of Illinois at Chicago in Google Maps

University of Chicago Cancer Research Center

Chicago, United States

Louis A. Weiss Memorial Hospital

Chicago, United States

Cancer Care Specialists of Central Illinois, S.C.

Decatur, United States
Completed11 Study Centers