Brief Title
ILX-295501 in Treating Patients With Stage III or Stage IV Ovarian Cancer That Has Not Responded to Previous Treatment
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
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 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.
Study Phase
Phase 2
Study Type
Interventional
Condition
Fallopian Tube Cancer
Intervention
ILX-295501
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
0
Start Date
May 1999
Eligibility Criteria
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
Gender
Female
Ages
18 Years - 120 Years
Accepts Healthy Volunteers
No
Contacts
Gayle Cook, RN, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00005645
Organization ID
CDR0000067825
Secondary IDs
ILEX-295501-211
Study Sponsor
Genzyme, a Sanofi Company
Study Sponsor
Gayle Cook, RN, Study Chair, Genzyme, a Sanofi Company
Verification Date
February 2001