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 newly diagnosed with 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.
Primary Peritoneal Cancer
Fallopian Tube Cancer
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Study of Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer|
- To determine the completion rate of six cycles of carboplatin/paclitaxel in this elderly population with no dose reductions because of toxicities. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]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.
- Assess CA125 response rates in this group of patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assess significant toxicities in this group of patients and compare to a non-elderly population [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Assess quality of life changes during chemotherapy [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Assess overall survival for this group of patients. [ Time Frame: TBD ] [ Designated as safety issue: No ]
|Study Start Date:||April 2006|
|Study Completion Date:||April 2010|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
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.
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02155|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Ursula Matulonis, MD||Dana-Farber Cancer Institute|