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

• 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 ]

• Assess CA125 response rates in this group of patients
• assess significant toxicities in this group of patients and compare to a non-elderly population
• assess quality of life changes during chemotherapy
• assess overall survival for this group of patients.

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.

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.

• Ovarian Cancer
• Primary Peritoneal Cancer
• Fallopian Tube Cancer
• Mesodermal Tumors

• Drug: Paclitaxel
  Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)
• Drug: Carboplatin
  Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)

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 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 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

• Brigham and Women's Hospital
• Massachusetts General Hospital