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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
Sponsor:
Collaborators:
Massachusetts General Hospital
Brigham and Women's Hospital
Information provided by (Responsible Party):
Ursula A. Matulonis, MD, Dana-Farber Cancer Institute

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
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

Resource links provided by the National Library of Medicine


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, Older Adult)
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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Information from the National Library of Medicine

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


Locations
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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
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Principal Investigator: Ursula Matulonis, MD Dana-Farber Cancer Institute
More Information
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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
Keywords provided by Ursula A. Matulonis, MD, Dana-Farber Cancer Institute:
platinum-sensitive recurrence
carboplatin
pemetrexed
Additional relevant MeSH terms:
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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