Abraxane Plus Carboplatin for Recurrent Platinum-Sensitive Ovarian Cancer

October 7, 2011 updated by: Southeastern Gynecologic Oncology

A Phase II, Non-Randomized Study of Abraxane Plus Carboplatin in Patients With Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

The purpose of this study is to determine if the combination of Abraxane and Carboplatin together will improve the chances of controlling recurrent ovarian/fallopian tube/peritoneal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Current best practice recommends Carboplatin combined with Taxol in the treatment of Ovarian cancer.

Taxol is paclitaxel in the solvent Cremophor-El and the solvent has been associated with significant side effects e.g. anaphylaxis and hypersensitivity. this requires the routine use of premedication with antihistamines and steroids.

Abraxane by contrast is Cremophor-El free and is protein bound. This has 2 advantages over Taxol.

  1. No need for routine premedications
  2. Increased drug entry into cells facilitating greater potential for anti-tumor activity.

Schedule: Carboplatin day1 every 28days. Abraxane day1,8,15 every 28days.

Study Type

Interventional

Enrollment (Anticipated)

40

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
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Southeastern Gynecologic Oncology

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Histologically or cytologically confirmed recurrent epithelial ovarian or primary peritoneal carcinoma. Patient will have been staged at diagnosis according to FIGO Classification.
  2. Measurable Disease by RECIST Criteria (defined by the presence of at least 1 measurable lesion (see Section 7.7.1 for definition of measurable lesions) or elevated CA-125 in the absence of measurable disease. A pre-treatment sample of CA-125 will be collected within 2 weeks before treatment is started. A pre-treatment sample of CA-125 should be at least twice the upper limit of normal.
  3. Patients must have disease recurrence 6 months or more after completion of front-line platinum and paclitaxel-containing regimen. Duration of response from prior therapy and prior consolidation therapy will be documented in case report forms for descriptive analysis.
  4. Patients must have received at least 3 cycles of a front-line taxane and platinum-containing regimen prior to entry on this study.
  5. Patients must have a documented complete clinical response on front-line therapy.
  6. Patients must be disease-free from prior malignancies for more than 5 years with the exception of curatively-treated basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.
  7. Life expectancy of > 6 months.
  8. ECOG (Zubrod) performance status 0-2.
  9. Age >18 years.

  10. Patient has the following blood counts at Baseline:

    • ANC > 1.5 x 10-9 c/L;
    • platelets > 100 x 10-9 c/L;
    • Hgb > 9 g/dL.

  11. Patient has the following blood chemistry levels at Baseline:

    • AST (SGOT), ALT (SGPT) < 1.5x upper limit of normal range (ULN);
    • total bilirubin NORMAL;
    • alkaline phosphatase < 2.5x ULN
    • creatinine < 1.5 mg/dL.
  12. Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent form prior to participation in any study-related activities.

Exclusion Criteria:

  1. Patients who have received more than one prior chemotherapy regimen.
  2. Evidence of active brain metastases, including leptomeningeal involvement. Prior evidence of brain metastasis permitted only if treated and stable off therapy for at least 1 month.
  3. Patient has pre-existing peripheral neuropathy of grade >/= 2 (per National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events version 3.0 [CTCAE].
  4. Patients receiving concurrent or intervening other chemotherapy, hormonal (for treatment of ovarian carcinoma), immunotherapy, or radiotherapy.
  5. Patient has a clinically significant concurrent illness.
  6. Patient is, in the Investigator's opinion, unlikely to be able to complete the study through the End of Study (EOS) visit.
  7. Patient has a history of allergy or hypersensitivity to the study drug.
  8. Patient has serious medical risk factors involving any of the major organ systems such that the investigator considers it unsafe for the patient to receive an experimental research drug.
  9. Patient is enrolled in any other clinical protocol or investigational trial.
  10. Patients of childbearing potential, not practicing adequate contraception.

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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Response Rate
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 5 years
5 years
Progression Free Survival
Time Frame: 5 years
5 years
Safety
Time Frame: 5 years
5 years
Time to Response
Time Frame: 5 years
5 years
Duration of Response
Time Frame: 5 years
5 years
Tolerability
Time Frame: 5 years
5 years

Collaborators and Investigators

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

Sponsor

Southeastern Gynecologic Oncology

Collaborators

Celgene Corporation

Investigators

  • Principal Investigator: Benidict B Benigno, MD, Southeastern Gynecologic Oncology

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

November 1, 2005

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

April 26, 2007

First Submitted That Met QC Criteria

April 26, 2007

First Posted (Estimate)

April 27, 2007

Study Record Updates

Last Update Posted (Estimate)

October 12, 2011

Last Update Submitted That Met QC Criteria

October 7, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WIRB#20051730

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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