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

September 16, 2018 updated by: Genzyme, a Sanofi Company

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genzyme, a Sanofi Company

Investigators

  • Study Chair: Gayle Cook, RN, Genzyme, a Sanofi Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 1999

Study Registration Dates

First Submitted

May 2, 2000

First Submitted That Met QC Criteria

May 25, 2004

First Posted (Estimate)

May 26, 2004

Study Record Updates

Last Update Posted (Actual)

September 18, 2018

Last Update Submitted That Met QC Criteria

September 16, 2018

Last Verified

February 1, 2001

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000067825
  • ILEX-295501-211
  • CND-99-039
  • UCLA-9908032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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