Cisplatin and Paclitaxel in Treating Patients With Stage IIB, Stage IIC, Stage III, or Stage IV Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cavity Cancer

December 29, 2014 updated by: Gynecologic Oncology Group

A Phase I Feasibility Trial IP Cisplatin and IV Paclitaxel on Day 1 Followed by IP Paclitaxel on Day 8 Every 21 Days as Front-Line Treatment of Ovarian, Fallopian Tube and Primary Peritoneal Carcinoma

This phase I trial is studying the side effects and best dose of cisplatin given together with paclitaxel in treating patients with stage IIB, stage IIC, stage III, or stage IV ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cavity cancer. Drugs used in chemotherapy, such as cisplatin and paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them in different ways may kill more tumor cells.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the feasibility of intraperitoneal (IP) cisplatin and intravenous (IV) paclitaxel followed by IP paclitaxel in patients with stage IIB, IIC, III, or IV ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer.

SECONDARY OBJECTIVES:

I. Assess the toxicity of this regimen in these patients. II. Determine the types of surgical and catheter complications that may occur after surgery or during the course of treatment in these patients.

III. Estimate the response rate in patients with measurable disease treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months for 1 year.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Phase 1

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago Comprehensive Cancer Center
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Cooper Hospital University Medical Center
    • Ohio
      • Columbus, Ohio, United States, 43214
        • Riverside Methodist Hospital
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Tulsa Cancer Institute
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Women and Infants Hospital
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital and Clinics

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

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal cavity cancer

    • Stage IIB, IIC, III, or IV disease

    • Optimal or suboptimal residual disease after debulking surgery within the past 12 weeks

      • Appropriate tissue for histologic evaluation available

  • The following histologic epithelial cell types are eligible:

    • Serous adenocarcinoma
    • Endometrioid adenocarcinoma
    • Mucinous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Transitional cell carcinoma
    • Malignant Brenner tumor
    • Adenocarcinoma not otherwise specified
    • Carcinosarcoma
  • No ovarian epithelial carcinoma of low malignant potential (borderline carcinomas)

  • No synchronous primary endometrial cancer or a history of primary endometrial cancer unless all of the following conditions are met:

    • Stage ≤ IB disease
    • No more than superficial myometrial invasion, without vascular or lymphatic invasion
    • No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO grade 3 lesion
  • GOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Serum creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Bilirubin ≤ 1.5 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • SGOT ≤ 2.5 times ULN
  • Audiograms required after study chemotherapy courses 3 and 6 for patients with hearing loss, or who are experiencing tinnitus during study therapy
  • Negative pregnancy test
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

  • None of the following:

    • Septicemia
    • Severe infection requiring parenteral antibiotics
    • Malnutrition requiring parenteral hyperalimentation
    • Acute hepatitis
    • Any other major medical conditions expected to interfere with completion of protocol therapy
  • No active bleeding
  • No circumstances that would prohibit completion of study therapy or required follow-up
  • No history of allergic reaction to polysorbate 80 (e.g., etoposide or vitamin E)
  • No other invasive malignancies, except for nonmelanoma skin cancer or other specific malignancies within the past 5 years, or whose previous cancer treatment contraindicates this protocol therapy

  • No unstable angina or myocardial infarction within the past 6 months

    • Abnormal cardiac conduction (e.g., bundle branch block or heart block) that has been stable for the past 6 months allowed

  • No prior targeted therapy for the management of ovarian epithelial or primary peritoneal cavity cancer including, but not limited to, the following:

    • Vaccines
    • Antibodies
    • Tyrosine kinase inhibitors
  • No prior chemotherapy
  • No prior radiotherapy
  • No prior hormonal therapy for the management of epithelial ovarian or primary peritoneal cavity cancer

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: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Treatment (paclitaxel, cisplatin)
Patients receive paclitaxel IV over 3 hours and cisplatin intraperitoneally (IP) on day 1 and paclitaxel IP on day 8. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Drug: Paclitaxel
Given IV or intraperitoneally
Other Names:
  • Anzatax
  • TAX
Drug: Cisplatin
Given intraperitoneally

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients who have at least 1 dose-limiting toxicity or delay in therapy for more than 2 weeks
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Grade of toxicity as assessed by Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
Time Frame: Up to 1 year
Up to 1 year
Adverse events related to the catheter or the surgical placement of the catheter
Time Frame: Up to 1 year
Up to 1 year
Objective tumor response (partial or complete) assessed by Response Evaluation Criteria for Solid Tumors (RECIST)
Time Frame: Up to 1 year
Up to 1 year

Collaborators and Investigators

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

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

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, 2009

Primary Completion (ACTUAL)

July 1, 2011

Study Registration Dates

First Submitted

December 20, 2008

First Submitted That Met QC Criteria

December 20, 2008

First Posted (ESTIMATE)

December 23, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

December 31, 2014

Last Update Submitted That Met QC Criteria

December 29, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GOG-9921 (OTHER: CTEP)
  • U10CA027469 (U.S. NIH Grant/Contract)
  • NCI-2009-00624 (REGISTRY: CTRP (Clinical Trial Reporting Program))
  • CDR0000629746

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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