Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
1 other identifier
interventional
44
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 ovarian-cancer
Started Sep 2005
Typical duration for phase_2 ovarian-cancer
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 29, 2005
CompletedFirst Posted
Study publicly available on registry
October 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedAugust 13, 2018
August 1, 2018
1.8 years
September 29, 2005
August 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To assess the response rate of carboplatin in combination with pemetrexed in patients with recurrent platinum-sensitive epithelial ovarian cancer, fallopian tube cancer or peritoneal cancer.
This study has now been published: Matulonis U.A.,Horowitz N, Campos S, Lee H., Lee J., Krasner C., Berlin S., Roche M., Duska L, Pereira L, Kendall D, Penson R. Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer. J Clin Oncol. 2008:26(35):5761-6
2 years
Secondary Outcomes (2)
To assess time to progression, progression-free survival, and overall survival in this patient population
to assess toxicities of treatment with combination carboplatin and pemetrexed.
2 years
Study Arms (1)
Carboplatin / Pemetrexed
EXPERIMENTALSingle Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2
Interventions
Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
Eligibility Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Massachusetts General Hospitalcollaborator
- Brigham and Women's Hospitalcollaborator
Study Sites (3)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ursula Matulonis, MD
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Medical Oncologist
Study Record Dates
First Submitted
September 29, 2005
First Posted
October 3, 2005
Study Start
September 1, 2005
Primary Completion
July 1, 2007
Study Completion
April 1, 2011
Last Updated
August 13, 2018
Record last verified: 2018-08