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Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer

Primary Purpose

Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Carboplatin
Pemetrexed
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Cancer focused on measuring platinum-sensitive recurrence, carboplatin, pemetrexed

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Massachusetts General Hospital
  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Carboplatin / Pemetrexed

Arm Description

Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2

Outcomes

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.
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
to assess toxicities of treatment with combination carboplatin and pemetrexed.

Full Information

First Posted
September 29, 2005
Last Updated
August 10, 2018
Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00230542
Brief Title
Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer
Official Title
Phase II Study of Carboplatin and Pemetrexed in Patients With Recurrent Platinum Sensitive Ovarian, Fallopian Tube or Primary Peritoneal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute
Collaborators
Massachusetts General Hospital, Brigham and Women's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer
Keywords
platinum-sensitive recurrence, carboplatin, pemetrexed

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ursula Matulonis, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States

12. IPD Sharing Statement

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Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer

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