Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer

This study has been completed.
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00230542
First received: September 29, 2005
Last updated: March 29, 2013
Last verified: March 2013

September 29, 2005
March 29, 2013
September 2005
July 2007   (final data collection date for primary outcome 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. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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
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.
Complete list of historical versions of study NCT00230542 on ClinicalTrials.gov Archive Site
  • To assess time to progression, progression-free survival, and overall survival in this patient population [ Time Frame: TBD ] [ Designated as safety issue: No ]
  • to assess toxicities of treatment with combination carboplatin and pemetrexed. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
  • 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.
Not Provided
Not Provided
 
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

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.

  • 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.
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Drug: Carboplatin
    Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
  • Drug: Pemetrexed
    Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
    Other Name: Alimta
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
April 2011
July 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00230542
05-220
Yes
Ursula A. Matulonis, MD, Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
  • Massachusetts General Hospital
  • Brigham and Women's Hospital
Principal Investigator: Ursula Matulonis, MD Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP