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	Treatment or Intervention	Phase
recurrent pancreatic cancer stage IVA pancreatic cancer stage IVB pancreatic cancer adenocarcinoma of the pancreas	Drug: dolastatin 10	Phase II

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--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

--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

--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

Illinois
      University of Chicago Cancer Research Center, Chicago,  Illinois,  60637,  United States
Texas
      University of Texas - MD Anderson Cancer Center, Houston,  Texas,  77030,  United States

Study chairs or principal investigators

Robert A. Wolff,  Study Chair,  M.D. Anderson Cancer Center   

Study ID Numbers:  CDR0000066778; MDA-DM-98071; NCI-T98-0028
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003677
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08