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

Phase 2
18 Years
Open (Enrolling)
Fallopian Tube Cancer, Metastatic Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

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Trial Information

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

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.

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Gayle Cook, RN

Investigator Role:

Study Chair

Investigator Affiliation:



United States: Federal Government

Study ID:




Start Date:

May 1999

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Metastatic Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage III ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • recurrent ovarian epithelial cancer
  • liver metastases
  • malignant pericardial effusion
  • malignant pleural effusion
  • malignant ascites
  • fallopian tube cancer
  • primary peritoneal cavity cancer
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Barnes-Jewish Hospital Saint Louis, Missouri  63110
Sarah Cannon-Minnie Pearl Cancer Center Nashville, Tennessee  37203
Virginia Mason Medical Center Seattle, Washington  98111
St. Vincents Comprehensive Cancer Center New York, New York  10011
Mercy Medical Center, Inc. Baltimore, Maryland  21202
Billings Oncology Associates Billings, Montana  59101