Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00003677
Recruitment Status : Completed
First Posted : July 22, 2004
Last Update Posted : July 30, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Drug: Dolastatin 10 Phase 2

Detailed Description:

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Dolastatin 10 (NSC# 376128) Administered Intravenously Every 21 Days to Patients With Metastatic Pancreatic Adenocarcinoma
Study Start Date : March 1999
Actual Primary Completion Date : January 2002
Actual Study Completion Date : January 2002

Resource links provided by the National Library of Medicine

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 :
  1. Number of Patients with Toxicity [ Time Frame: Every 3 months ]
    Toxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically confirmed metastatic adenocarcinoma of the pancreas Bidimensionally measurable lesions with sentinel lesions outside field of any prior radiation therapy No brain metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-1 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count at least 1500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No active congestive heart failure No uncontrolled angina At least 6 months since prior myocardial infarction No uncontrolled hypertension Other: Not pregnant or nursing Fertile patients must use effective contraception No concurrent serious infection At least 5 years since prior malignancy except the following: Nonmelanoma skin cancer Carcinoma in situ of the cervix No overt psychosis or mental disability

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent biologic therapy Chemotherapy: No prior chemotherapy for metastatic disease At least 6 months since prior adjuvant chemotherapy No concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 6 months since prior adjuvant chemoradiation to disease At least 2 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior surgery and recovered No concurrent surgery Other: At least 4 weeks since prior investigational drug (including analgesics or antiemetics) No other concurrent anticancer therapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00003677

United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637
United States, Texas
University of Texas - MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Hedy L. Kindler, MD University of Chicago

Additional Information:
Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00003677     History of Changes
Other Study ID Numbers: 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: UT MD Anderson Cancer Center )
CDR0000066778 ( Registry Identifier: NCI PDQ )
First Posted: July 22, 2004    Key Record Dates
Last Update Posted: July 30, 2012
Last Verified: July 2012

Keywords provided by M.D. Anderson Cancer Center:
recurrent pancreatic cancer
adenocarcinoma of the pancreas
stage IV pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Dolastatin 10
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action