Carboplatin and Pemetrexed in Recurrent Platinum Sensitive Ovarian Cancer

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

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.

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

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.

Secondary Outcome

 To assess time to progression, progression-free survival, and overall survival in this patient population

Condition

Ovarian Cancer

Intervention

Carboplatin

Study Arms / Comparison Groups

 Carboplatin / Pemetrexed

Description:  Single Arm Study Carboplatin AUC 5 Pemetrexed 500 mg/m2

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Drug

Estimated Enrollment

Start Date

September 2005

Completion Date

April 2011

Primary Completion Date

July 2007

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

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Ursula Matulonis, MD, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT00230542

Organization ID

05-220

Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Collaborators

 Massachusetts General Hospital

Study Sponsor

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

Verification Date

August 2018