Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00003677

Collaborator

National Cancer Institute (NCI) (NIH)

Enrollment

Locations

Arm

35.5

Actual Duration (Months)

4.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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 Design

Study Type:

Interventional

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

Actual Study Start Date :

Feb 1, 1999

Actual Primary Completion Date :

Jan 16, 2002

Actual Study Completion Date :

Jan 16, 2002

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dolastatin 10 Dolastatin 10 IV bolus once every 21 days.	Drug: Dolastatin 10 IV bolus once every 21 days.

Arm

Intervention/Treatment

Experimental: Dolastatin 10

Dolastatin 10 IV bolus once every 21 days.

Drug: Dolastatin 10

IV bolus once every 21 days.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Cancer Research Center	Chicago	Illinois	United States	60637
2	University of Texas - MD Anderson Cancer Center	Houston	Texas	United States	77030