ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment

Ovarian Cancer Clinical Trial

Official title:

Phase II Trial of ILX295501 Administered Orally Once Weekly x 3 Repeated Every 6 Weeks in Patients With Stage III/IV Ovarian Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00005645
• Other study ID #: CDR0000067825
• Secondary ID: ILEX-295501-211C
• Status: Withdrawn
• Phase: Phase 2
• Start date: May 1999

Study information

• Verified date: February 2001
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS: Histologically confirmed stage III or IV ovarian epithelial cancer, including fallopian tube and extraovarian carcinoma Cytological confirmation in the presence of clear clinical and radiological features of disease allowed Refractory to at least two prior chemotherapy regimens for advanced or metastatic disease At least one taxane/platinum containing regimen with or without one topotecan regimen Recurrent or progressive disease while on or within 6 months of last therapy regimen Must have progressed on or within 3 months of receiving topotecan as last therapy regimen Measurable disease outside previously irradiated field OR Objective evidence of disease progression if within previously irradiated field CA 125 at least 35 units/mL No CNS metastases or carcinomatous meningitis

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hemoglobin at least 9.0 g/dL Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) AST and ALT no greater than 3 times ULN (no greater than 5 times ULN if liver metastases present) Albumin greater than 2.5 g/dL Renal: Creatinine no greater than ULN Other: No known hypersensitivity to sulfa compounds No known glucose-6-phosphate dehydrogenase deficiency No active or uncontrolled infection No other malignancy within the past 2 years No other severe disease including neurologic or psychiatric disorders that would preclude study Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Chemotherapy: See Disease Characteristics At least 4 weeks since prior chemotherapy and recovered No other concurrent chemotherapy Endocrine therapy: No concurrent hormonal therapy, excluding contraceptives or corticosteroids Radiotherapy: See Disease Characteristics Prior radiotherapy to less than 25% bone marrow allowed No prior whole pelvic radiotherapy At least 4 weeks since prior radiotherapy and recovered No concurrent radiotherapy Surgery: At least 4 weeks since prior major surgery and recovered Other: At least 4 weeks since prior investigational agents No other concurrent investigational agents

Related Conditions & MeSH terms

• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Metastatic Cancer
• Neoplasm Metastasis
• Neoplasms, Glandular and Epithelial
• Ovarian Cancer
• Ovarian Neoplasms
• Peritoneal Neoplasms
• Primary Peritoneal Cavity Cancer

Intervention

Drug:
• ILX-295501

Locations

Country	Name	City	State
United States	Mercy Medical Center, Inc.	Baltimore	Maryland
United States	Billings Oncology Associates	Billings	Montana
United States	Indiana University Cancer Center	Indianapolis	Indiana
United States	Jonsson Comprehensive Cancer Center, UCLA	Los Angeles	California
United States	Sarah Cannon-Minnie Pearl Cancer Center	Nashville	Tennessee
United States	St. Vincents Comprehensive Cancer Center	New York	New York
United States	Barnes-Jewish Hospital	Saint Louis	Missouri
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Country where clinical trial is conducted

United States,