Status:
COMPLETED
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
Lead Sponsor:
Dana-Farber Cancer Institute
Collaborating Sponsors:
Massachusetts General Hospital
Brigham and Women's Hospital
Conditions:
Ovarian Cancer
Peritoneal Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the effects (good and bad) the combination of carboplatin and pemetrexed have on patients with recurrent ovarian, peritoneal, or fallopian tube cancer.
Detailed Description
* Before patients receive any chemotherapy treatments they will be given three medications to prevent side effects from the chemotherapy drugs. These medications are vitamin B12, folic acid and dexame...
Eligibility Criteria
Inclusion
- Diagnosis of platinum-sensitive recurrence of epithelial ovarian cancer, primary peritoneal cancer, or fallopian tube cancer
- The following histologic subtypes are eligible: papillary serous, endometrioid, mucinous, clear cell, adenocarcinomas, transitional, and mixtures of the above.
- At least one measurable lesion according to RECIST criteria via CT or MRI scan
- Received a platinum-containing regimen at initial diagnosis
- ECOG performance status of 0,1 or 2
- 18 years of age or older
- Life expectancy of greater than 12 weeks
- WBC \> 1,500/mm3
- Neutrophils \> 1,500/mm3
- Platelets \> 100,000/mm3
- Total Bilirubin \< 1.5 ULN
- Calculated creatinine clearance \> 45 ml/min
- ALT/AST \< 3 x ULN (no liver mets) ALT/AST \< 5 x ULN (with liver mets)
- Complete recovery from completion of previous chemotherapy or biologic therapy
- Negative pregnancy test and agree to practice effective method of birth control
Exclusion
- Patients with sarcomatous, stromal, or germ cell elements
- Prior pelvic radiotherapy \> 25% of bone marrow
- 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 unless the patient has had treatment with surgery or radiation therapy, is neurologically stable, and does not require oral or intravenous corticosteroids or anticonvulsants
- Prior malignancy except adequately treated carcinoma in situ of the uterine cervix, incidental stage I endometrial cancer, basal cell or squamous cell skin cancer or breast cancer (invasive or ductal carcinoma in situ) of which the patient has been disease-free for at least five years
- Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks
- Clinically significant cardiac disease as defined by: history of unstable angina within 6 months; history of symptomatic ventricular arrhythmias; history of congestive heart failure; history of myocardial infarction within 6 months
- Uncontrolled hypercalcemia or diabetes mellitus
- Any signs of intestinal obstruction with bowel function and/or nutrition
- Grade 2 or greater peripheral neuropathy
- Participation in an investigational study within three weeks
- History of anaphylactic shock to prior platinum chemotherapy
- History of psychiatric disability or other central nervous system disorder
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00230542
Start Date
September 1 2005
End Date
April 1 2011
Last Update
August 13 2018
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115