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

Phase 2
70 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cancer, Fallopian Tube Cancer, Mesodermal Tumors

Thank you

Trial Information

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

There has been little research on women who have ovarian, peritoneal or fallopian tube
cancer that are 70 years of age or older. We are interested in finding out the special side
effects these patients may have with their chemotherapy treatment. This trial will follow
patients while they are receiving standard chemotherapy.

Prior to starting chemotherapy treatment, once during chemotherapy treatment and up to one
year following chemotherapy patients will receive 5 questionnaires to complete. These
questionnaires will ask questions about quality of life, whether the patient is experiencing
neuropathy (tingling and/or pain in the fingertips and toes), the level of tiredness, and
what type of activities are performed without difficulty and if their activity level changes
while they are receiving chemotherapy.

Blood tests to check the levels of both taxol and carboplatin will be performed just before
and during the first cycle of chemotherapy.

Inclusion Criteria:

- Age 70 or older

- 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

- 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 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

- History of psychiatric disability or other central nervous system disorder

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the completion rate of six cycles of carboplatin/paclitaxel in this elderly population with no dose reductions because of toxicities.

Outcome Description:

This trial has now been published with the following reference: Matulonis, U.A., Krag, KJ, Krasner CN, Atkinston T., Horowitz NS, Lee H., Penson RT. Phase II prospective study of paclitaxel and carboplatin in older patients with newly diagnosed Mullerian tumors. Gynecologic Oncology 2009:112(2):394-9.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ursula Matulonis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

April 2006

Completion Date:

April 2010

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cancer
  • Fallopian Tube Cancer
  • Mesodermal Tumors
  • carboplatin
  • paclitaxel
  • elderly women
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617