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

Brief Title

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

Official Title

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

Brief Summary

      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.

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 Phase

Phase 2

Study Type

Interventional

Primary Outcome

Therapy Completion Rate

Condition

Ovarian Cancer

Intervention

Paclitaxel

Study Arms / Comparison Groups

 Carboplatin/Paclitaxel

Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

April 2006

Completion Date

April 2010

Primary Completion Date

April 2008

Eligibility Criteria

        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

Gender

Female

Ages

70 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ursula Matulonis, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00322881

Organization ID

05-402

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Brigham and Women's Hospital

Study Sponsor

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

Verification Date

August 2018