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Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal 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.

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

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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.

Outcome Description:

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

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Ursula Matulonis, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute


United States: Institutional Review Board

Study ID:




Start Date:

September 2005

Completion Date:

April 2011

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • platinum-sensitive recurrence
  • carboplatin
  • pemetrexed
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer Institute Boston, Massachusetts  02115
Brigham and Women's Hospital Boston, Massachusetts  02115
Massachusetts General Hospital Boston, Massachusetts  02114-2617