Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer - Full Text View

Purpose

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	Intervention	Phase
Ovarian Cancer Peritoneal Cancer Fallopian Tube Cancer	Drug: Carboplatin Drug: Pemetrexed	Phase 2


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Allergy Cancer Ovarian Cancer

Drug Information available for: Carboplatin Pemetrexed Pemetrexed disodium

Genetic and Rare Diseases Information Center resources: Ovarian Cancer Fallopian Tube Cancer

U.S. FDA Resources

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]


Enrollment:	44
Study Start Date:	September 2005
Study Completion Date:	April 2011
Primary Completion Date:	July 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00230542

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


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
Study First Received:	September 29, 2005
Last Updated:	March 29, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 23, 2016