Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer



Status:Completed
Conditions:Cancer, Cancer, Pancreatic Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/27/2018
Start Date:February 1, 1999
End Date:January 16, 2002

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Phase II Study of Dolastatin 10 (NSC# 376128) Administered Intravenously Every 21 Days to Patients With Metastatic Pancreatic Adenocarcinoma

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.

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
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1515 Holcombe Blvd
Houston, Texas 77030
 713-792-2121
University of Texas M.D. Anderson Cancer Center The mission of The University of Texas MD...
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