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Dolastatin 10 in Treating Patients With Metastatic Pancreatic Cancer

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00003677
Enrollment
9
Registered
2004-07-22
Start date
1999-02-01
Completion date
2002-01-16
Last updated
2018-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer, adenocarcinoma of the pancreas, stage IV pancreatic cancer

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.

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.

Interventions

IV bolus once every 21 days.

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients with ToxicityEvery 3 monthsToxic effects of dolastatin 10 therapy in patients with metastatic adenocarcinoma of the pancreas used to assess antitumor activity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026