Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

August 10, 2018 updated by: Ursula A. Matulonis, MD, Dana-Farber Cancer Institute

A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer

The main purpose of this trial is to look at how elderly women (70 years of age or older) with newly diagnosed ovarian, peritoneal, or fallopian tube cancer manage six cycles of carboplatin and paclitaxel, what side effects they experience, and how their cancer reacts or responds to standard carboplatin and paclitaxel chemotherapy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

•To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities.

Secondary

  • Assess cancer antigen 125 (CA125) response rates of paclitaxel/carboplatin in this group of patients
  • Assess significant toxicities in this group of patients and compare to a non-elderly population.
  • To determine which clinical parameters will predict lack of completion of six cycles of carboplatin and paclitaxel chemotherapy.
  • Assess quality of life changes during chemotherapy and up to one year after completion of chemotherapy.
  • Assess progression-free survival and overall survival for this group.
  • To determine the feasibility of accrual.

STATISTICAL DESIGN:

Using a one sample binomial design, with 37 patients there was 83% power to detect a null hypothesis of a 45% therapy completion rate versus an alternative hypothesis of a 66% rate assuming a one-sided 5% alpha. The regimen would be declared ineffective if there were 19 or fewer patients who completed 6 cycles of carboplatin and paclitaxel chemotherapy without dose adjustments.

Study Type

Interventional

Enrollment (Actual)

12

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
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
      • Boston, Massachusetts, United States, 02155
        • Dana-Farber Cancer Institute

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age 70 or older
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0,1 or 2 and is medically eligible and clinically appropriate to receive systemic chemotherapy
  • Diagnosis of ovarian, primary peritoneal, fallopian tube cancer, papillary serous cancer of the endometrium, or mixed mesodermal tumors of the ovary, fallopian tube or uterus
  • Life expectancy greater than 6 months
  • Baseline laboratory values as described in protocol

Exclusion Criteria:

  • Active infection requiring antibiotics at the time of starting chemotherapy
  • Prior pelvic radiotherapy > 25% of bone marrow
  • Any uncontrolled medical problem that in the opinion of the investigator would preclude safe administration of the study drugs
  • Past history of bone marrow transplantation or stem cell support
  • Known history of central nervous system (CNS) metastasis
  • History of prior malignancy that required prior systemic therapy
  • Clinically significant cardiac disease
  • Uncontrolled diabetes mellitus
  • Any signs of intestinal obstruction
  • Participation in an investigational drug study within three weeks prior to study entry
  • History of psychiatric disability or other central nervous system disorder

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carboplatin/Paclitaxel
Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
Drug: Carboplatin
Drug: Paclitaxel
Other Names:
  • Taxol

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Therapy Completion Rate
Time Frame: 6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.
The therapy completion rate is the proportion of patients who completed 6 cycles of carboplatin/paclitaxel therapy without dose reductions.
6 cycles of therapy, up to approximately 4.5 months given the cycle length of 21 days.

Collaborators and Investigators

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

Sponsor

Dana-Farber Cancer Institute

Collaborators

Massachusetts General Hospital
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Ursula Matulonis, MD, Dana-Farber Cancer Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2006

Primary Completion (Actual)

April 1, 2008

Study Completion (Actual)

April 1, 2010

Study Registration Dates

First Submitted

May 5, 2006

First Submitted That Met QC Criteria

May 5, 2006

First Posted (Estimate)

May 8, 2006

Study Record Updates

Last Update Posted (Actual)

September 10, 2018

Last Update Submitted That Met QC Criteria

August 10, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-402

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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