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


Phase 2
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients with Toxicity

Outcome Description:

Toxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.

Outcome Time Frame:

Every 3 months

Safety Issue:

No

Principal Investigator

Hedy L. Kindler, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Chicago

Authority:

United States: Federal Government

Study ID:

DM98-071

NCT ID:

NCT00003677

Start Date:

March 1999

Completion Date:

January 2002

Related Keywords:

  • Pancreatic Cancer
  • recurrent pancreatic cancer
  • adenocarcinoma of the pancreas
  • stage IV pancreatic cancer
  • Adenocarcinoma
  • Pancreatic Neoplasms

Name

Location

University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Chicago Cancer Research CenterChicago, Illinois  60637