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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To determine the completion rate of six cycles of carboplatin/paclitaxel in this elderly population with no dose reductions because of toxicities.
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.
Ursula Matulonis, MD
Dana-Farber Cancer Institute
United States: Institutional Review Board
|Dana-Farber Cancer Institute||Boston, Massachusetts 02115|
|Massachusetts General Hospital||Boston, Massachusetts 02114-2617|