Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer; Peritoneal Cancer; Fallopian Tube Cancer	Drug: Carboplatin; Drug: Pemetrexed	Phase 2

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	44 participants
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

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Carboplatin / Pemetrexed; Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2	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

Outcome Measures

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Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. To assess time to progression, progression-free survival, and overall survival in this patient population
2. to assess toxicities of treatment with combination carboplatin and pemetrexed. [ Time Frame: 2 years ]

Eligibility Criteria

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

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

Contacts and Locations

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Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Massachusetts General Hospital

Brigham and Women's Hospital

Investigators

Principal Investigator:	Ursula Matulonis, MD	Dana-Farber Cancer Institute

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Ursula A. Matulonis, MD, Medical Oncologist, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00230542 History of Changes
Other Study ID Numbers:	05-220
First Posted:	October 3, 2005
Last Update Posted:	March 23, 2017
Last Verified:	March 2017

Keywords provided by Ursula A. Matulonis, MD, Dana-Farber Cancer Institute:

platinum-sensitive recurrence; carboplatin; pemetrexed

Additional relevant MeSH terms:

Ovarian Neoplasms; Fallopian Tube Neoplasms; Peritoneal Neoplasms; Hypersensitivity; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Neoplasms, Female; Urogenital Neoplasms; Endocrine System Diseases; Gonadal Disorders	Fallopian Tube Diseases; Abdominal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Immune System Diseases; Carboplatin; Pemetrexed; Antineoplastic Agents; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors