Trials / Withdrawn
WithdrawnNCT00003821
Aminopterin in Treating Patients With Recurrent or Refractory Endometrial Cancer
Phase II Trial of Aminopterin in Patients With Persistent or Recurrent Endometrial Carcinoma
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- Female
- Age
- 120 Years
- Healthy volunteers
- Not accepted
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 aminopterin in treating patients who have refractory or recurrent endometrial cancer.
Detailed description
OBJECTIVES: I. Estimate the antitumor activity of aminopterin in patients with persistent, recurrent, or refractory endometrial carcinoma who have failed prior first line cytotoxic chemotherapy. II. Determine the quantitative and qualitative toxic effects of aminopterin in this patient population. III. Determine the overall patient survival and time to progression of these patients. IV. Assess the pharmacokinetic profile of these patients. OUTLINE: Patients receive oral aminopterin every 12 hours twice weekly. Treatment continues for up to 15 months in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until death. PROJECTED ACCRUAL: A total of 15-25 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | aminopterin |
Timeline
- Start date
- 1998-01-01
- First posted
- 2004-08-04
- Last updated
- 2018-09-18
Locations
6 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00003821. Inclusion in this directory is not an endorsement.