Brief Title
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
Official Title
Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
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 dexamethasone.
- Chemotherapy treatments will be given intravenously in the outpatient clinic. Pemetrexed
will be given first and will take 10 minutes to infuse followed by carboplatin which
will take 30-45 minutes to infuse. These treatments will be repeated once every three
weeks for 6 cycles of chemotherapy (18 weeks).
- Before each chemotherapy treatment the following tests and procedures will be performed:
physical exam and medical history; evaluation of ability to undertake daily activities;
and blood tests.
- After every 2 cycles of chemotherapy (every 6 weeks) patients will have a CT or MRI scan
to measure how well their cancer is responding to treatment.
- The study treatment will last for 6 cycles of chemotherapy as long as the tumor does not
grow and the patient isn't experiencing any severe side effects.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
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.
Secondary Outcome
To assess time to progression, progression-free survival, and overall survival in this patient population
Condition
Ovarian Cancer
Intervention
Carboplatin
Study Arms / Comparison Groups
Carboplatin / Pemetrexed
Description: Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
44
Start Date
September 2005
Completion Date
April 2011
Primary Completion Date
July 2007
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Ursula Matulonis, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00230542
Organization ID
05-220
Responsible Party
Principal Investigator
Study Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital
Study Sponsor
Ursula Matulonis, MD, Principal Investigator, Dana-Farber Cancer Institute
Verification Date
August 2018