Dolastatin 10 In Treating Patients With Metastatic Pancreatic Cancer

Study Overview

Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer

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 who have metastatic pancreatic cancer.

OBJECTIVES: I. Assess the antitumor activity of dolastatin 10 in patients with metastatic adenocarcinoma of the pancreas. II. Evaluate the qualitative and quantitative toxic effects of this therapy in these patients. III. Investigate the clinical pharmacology of this treatment. OUTLINE: This is an open label, multicenter study. Patients receive dolastatin 10 IV bolus once every 21 days. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: This study will accrue 12-37 patients within 18.5 months.

Pancreatic Cancer

DRUG: Dolastatin 10

DM98-071
P30CA016672 (U.S. NIH Grant/Contract)
U01CA070172 (U.S. NIH Grant/Contract)
U01CA063187 (U.S. NIH Grant/Contract)
MDA-DM-98071 (OTHER Identifier) (OTHER: UT MD Anderson Cancer Center)
NCI-T98-0028
CDR0000066778 (REGISTRY Identifier) (REGISTRY: NCI PDQ)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 1999-11-01	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2018-10-23
First Submitted that Met QC Criteria 2004-07-21	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2018-10-25
First Posted (ACTUAL) 2004-07-22	Results First Posted N/A	Last Verified 2018-10

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Non Randomized

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Dolastatin 10 Dolastatin 10 IV bolus once every 21 days.	DRUG: Dolastatin 10 IV bolus once every 21 days.

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Dolastatin 10

Dolastatin 10 IV bolus once every 21 days.

DRUG: Dolastatin 10

IV bolus once every 21 days.

Primary Outcome Measures	Measure Description	Time Frame
Number of Patients with Toxicity	Toxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.	Every 3 months

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

National Cancer Institute (NCI)

Investigators

STUDY_CHAIR: Hedy L. Kindler, MD, University of Chicago

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

Patients

Caregivers

Clinical Trial Record