Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
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ClinicalTrials.gov Identifier: NCT00230542 |
Recruitment Status :
Completed
First Posted : October 3, 2005
Last Update Posted : August 13, 2018
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Condition or disease | Intervention/treatment | Phase |
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Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer | Drug: Carboplatin Drug: Pemetrexed | Phase 2 |
- 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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 44 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer |
Study Start Date : | September 2005 |
Actual Primary Completion Date : | July 2007 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Carboplatin / Pemetrexed
Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2
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Drug: Carboplatin
Given intravenously following pemetrexed over 30-45 minutes once every three weeks for 6 cycles (18 weeks)
Other Name: Paraplatin Drug: Pemetrexed Given intravenously over 30 minutes once every three weeks for 6 cycles (18 weeks)
Other Name: Alimta |
- 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 ]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 time to progression, progression-free survival, and overall survival in this patient population
- to assess toxicities of treatment with combination carboplatin and pemetrexed. [ Time Frame: 2 years ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00230542
United States, Massachusetts | |
Massachusetts General Hospital | |
Boston, Massachusetts, United States, 02114 | |
Brigham and Women's Hospital | |
Boston, Massachusetts, United States, 02115 | |
Dana-Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Ursula Matulonis, MD | Dana-Farber Cancer Institute |
Responsible Party: | Ursula A. Matulonis, MD, Medical Oncologist, Dana-Farber Cancer Institute |
ClinicalTrials.gov Identifier: | NCT00230542 |
Other Study ID Numbers: |
05-220 |
First Posted: | October 3, 2005 Key Record Dates |
Last Update Posted: | August 13, 2018 |
Last Verified: | August 2018 |
platinum-sensitive recurrence carboplatin pemetrexed |
Ovarian Neoplasms Carcinoma, Ovarian Epithelial Fallopian Tube Neoplasms Hypersensitivity Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Fallopian Tube Diseases Immune System Diseases Carboplatin Pemetrexed Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Folic Acid Antagonists Nucleic Acid Synthesis Inhibitors |