Clinical trial NCT00230542: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Cancer
Peritoneal Cancer
Fallopian Tube Cancer
Keywords: platinum-sensitive recurrence
carboplatin
pemetrexed
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: Massachusetts General Hospital
name: Brigham and Women's Hospital
First posted: 2005-10-03
Enrollment: 44
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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.
timeFrame: 2 years
Secondary outcomes:
measure: To assess time to progression, progression-free survival, and overall survival in this patient population
measure: to assess toxicities of treatment with combination carboplatin and pemetrexed.
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Ursula Matulonis, MD
role: PRINCIPAL_INVESTIGATOR
References: