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

• Status: Terminated
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dana-Farber Cancer Institute
• Collaborators: Brigham and Women's Hospital; Massachusetts General Hospital
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

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