Trials / Withdrawn
WithdrawnNCT00005645
ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Genzyme, a Sanofi Company · Industry
- Sex
- Female
- Age
- 18 Years – 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 ILX-295501 in treating patients who have stage III or stage IV ovarian cancer that has not responded to previous therapy.
Detailed description
OBJECTIVES: I. Determine the objective response in patients with refractory stage III or IV ovarian epithelial cancer treated with ILX-295501. II. Determine the number of patients with at least 50% decrease in CA125 when treated with this regimen. III. Determine the time to tumor progression, overall survival, and toxicity profile in this patient population treated with this regimen. OUTLINE: This is a multicenter study. Patients receive oral ILX-295501 once weekly for 3 weeks. Treatment repeats every 6 weeks for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed at 1 month and then every 3 months until death. PROJECTED ACCRUAL: A total of 30-50 patients will be accrued for this study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ILX-295501 |
Timeline
- Start date
- 1999-05-01
- First posted
- 2004-05-26
- Last updated
- 2018-09-18
Locations
8 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00005645. Inclusion in this directory is not an endorsement.