Status:
TERMINATED
Carboplatin and Paclitaxel in Elderly Women With Newly Diagnosed Ovarian, Peritoneal, or Fallopian Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Brigham and Women's Hospital
Massachusetts General Hospital
Conditions:
Ovarian Cancer
Primary Peritoneal Carcinoma
Eligibility:
FEMALE
70+ years
Phase:
PHASE2
Brief 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 paclit...
Detailed Description
OBJECTIVES: Primary •To determine the completion rate of six cycles of carboplatin/paclitaxel with no dose reductions because of toxicities. Secondary * Assess cancer antigen 125 (CA125) response ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00322881
Start Date
April 1 2006
End Date
April 1 2010
Last Update
September 10 2018
Active Locations (2)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02155