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6-Hydroxymethylacylfulvene in Treating Patients With Stage III or Stage IV Pancreatic Cancer
This study is no longer recruiting patients.
Sponsored by: | San Antonio Cancer Institute |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
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 6-hydroxymethylacylfulvene in treating patients who have stage III or stage IV pancreatic cancer that cannot be surgically removed.
Condition | Treatment or Intervention | Phase |
---|---|---|
recurrent pancreatic cancer stage III pancreatic cancer stage IV pancreatic cancer adenocarcinoma of the pancreas |
Drug: -hydroxymethylacylfulvene |
Phase II |
MedlinePlus related topics: Pancreatic Cancer
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of 6-Hydroxymethylacylfulvene (MGI 114) in Patients with Stage III or IV Unresectable Adenocarcinoma of the Pancreas
Study start: October 1998
OBJECTIVES: I. Determine the survival rate at 6 months of patients with stage III or IV unresectable adenocarcinoma of the pancreas treated with 6-hydroxymethylacylfulvene (MGI 114).
II. Determine the objective tumor response rate, time to objective tumor response, and duration of response in these patients (if retrospective data is available, time to tumor progression while on prior gemcitabine is determined).
III. Determine the clinical benefit of MGI 114 as measured by pain improvement, performance status, and weight.
IV. Determine the survival rate at 3, 9, and 12 months in these patients.
V. Gain additional information on the toxic effects and safety profile of this regimen.
PROTOCOL OUTLINE: This is an open label, multicenter study.
Patients receive 6-hydroxymethylacylfulvene (MGI 114) IV over 5 minutes on days 1-5. Treatment is repeated every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed monthly for up to 1 year after therapy initiation.
PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study within 12-18 months.
Eligibility
Ages Eligible for Study: 18 Years and above
Criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Location Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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