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

Stopped early · Phase 2

Conditions studied: Ovarian Cancer, Primary Peritoneal Carcinoma, Fallopian Tube Cancer, Mixed Tumor, Mesodermal

In brief

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.

Key facts

Study ID

NCT00322881

Run by

Dana-Farber Cancer Institute

People needed

12

Starts

2006-04-01

Expected to finish

2010-04-01

Last updated by the study team

2018-09-10

Who can join

Age: 70 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dana-Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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