Phase II CT-2103/Carboplatin in Ovarian Cancer

September 18, 2008 updated by: CTI BioPharma

CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study

The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.

Study Type

Interventional

Enrollment (Actual)

82

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
      • Greenbrae, California, United States, 94904
        • California Cancer Care
      • Greenbrae, California, United States
        • Gynecology Oncology Associates
      • Stockton, California, United States, 95204
        • Stockton Hematology Oncology Medical
    • Florida
      • South Miami, Florida, United States, 33143
        • Raben and Fldman Research Associates
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
    • Missouri
      • Kansas City, Missouri, United States, 64132
        • Resource Center for Gynecology/ Oncology
    • New York
      • Rochester, New York, United States, 98104
        • Upstate New York Cancer Research and Education Foundation
    • Ohio
      • Columbus, Ohio, United States, 43222
        • Gynecology, Oncology, and Pelvic Surgery Associates, Inc.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19141
        • Albert Einstein Cancer Center
      • Sayre, Pennsylvania, United States, 18840
        • Guthrie Foundation for Education and Research
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • South Carolina Oncology Assoicates
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Chattanooga GYN-Oncology
      • Knoxville, Tennessee, United States, 37920
        • Baptist Regional Cancer Center
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Arlington Fairfax Hematology Oncology
    • Washington
      • Seattle, Washington, United States, 98104
        • Swedish Cancer Institute
      • Seattle, Washington, United States, 98104
        • Pacific Gynecology Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53201
        • Aurora Health Care, Inc.

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion criteria:

  • Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
  • Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
  • ECOG performance score of 0, 1, or 2.
  • absolute neutrophil count (ANC) at least 1,500/µL.
  • platelet at least 100,000/µL.
  • hemoglobin at least 10 g/dL.
  • creatinine no greater than 1.5 times the upper limit of normal (ULN).
  • bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN.
  • Alkaline phosphatase no greater than 2.5 x ULN.

Exclusion:

  • Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
  • Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
  • Synchronous primary endometrial cancer or history of primary endometrial cancer.
  • Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
  • Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
  • Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
  • Prior radiotherapy to any portion of the abdominal cavity or pelvis.
  • Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
  • Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks.
  • Presence of active hepatitis, either acute or chronic.
  • Presence of active infection requiring antibiotic or antiviral therapy.
  • Pregnant women or nursing mothers.

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
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

CTI BioPharma

Investigators

  • Study Director: Scott Stromatt, M.D., CTI BioPharma

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

February 1, 2003

Primary Completion (Actual)

November 1, 2005

Study Completion (Actual)

September 1, 2006

Study Registration Dates

First Submitted

October 2, 2003

First Submitted That Met QC Criteria

October 3, 2003

First Posted (Estimate)

October 6, 2003

Study Record Updates

Last Update Posted (Estimate)

September 22, 2008

Last Update Submitted That Met QC Criteria

September 18, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGT201

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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