Pemetrexed and Carboplatin in Recurrent Platinum Sensitive Ovarian Cancer
Conditions
Ovarian Cancer - Peritoneal Cancer - Fallopian Tube Cancer
Conditions: official terms
Ovarian Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Carboplatin Type: Drug
Name: Pemetrexed Type: Drug
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
Criteria: Inclusion Criteria:

- Patients must have a histopathologically confirmed diagnosis of epithelial ovarian, primary peritoneal, or fallopian tube carcinoma.

- Patients must have received at least 1 prior platinum and taxane based chemotherapy regimen. Patients may have failed no more than 2 prior chemotherapy regimens.

- Patients must have "platinum sensitive" disease, which will be defined as those patients with relapsed disease who had an initial complete remission, and relapsed more than 6 months after completion of initial platinum based chemotherapy.

- Bidimensionally measurable disease which can be measured by physical examination or by means of medical imaging techniques (measurable disease).

- OR Two confirmed serum CA-125 levels greater than or equal to 70 u/ml (or 2x upper limit of normal) separated by 1 week and obtained within 4 weeks prior to entry to the study (evaluable disease).

- Patients must not have had other myelosuppressive therapy within four weeks of initiating Pemetrexed / Carboplatin therapy.

- Patients must have recovered from effects of recent surgery.

- Patients must be at least 18 years of age.

- Patients must have a GOG performance status of 0, l, or 2.

- WBC > 3,00/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)

- SGOT, SGPT, alkaline phosphatase ≤ three times the upper normal institutional limits.

- All labs must be drawn within 4 weeks prior to entry to the study

- Patients must be willing to take the dexamethasone, folic acid and vitamin B12 supplementation as indicated in the protocol to reduce adverse drug toxicity.

- Patients must be willing to interrupt aspirin and other NSAID intake for 2 days before, day of, and 2 days after each chemotherapy treatment. Low dose 80mg aspirin and Cox-2 inhibitors are excluded from this restriction. If concomitant administration of an NSAID is necessary, patients should be monitored closely.

- Patients must have a life expectancy of greater than 12 weeks.

- Patients may not have concurrent or previous invasive malignancies, with the exception of non-melanoma skin cancer or no evidence of recurrence of previous malignancy within the last 5 years.

- Patients must have a current exam, bloodwork and any clinically indicated imaging studies within 4 weeks prior to study enrollment.

- Baseline folate and homocysteine blood levels.

- The ability to take folic acid, Vitamin B12, and dexamethasone according to protocol.

Exclusion Criteria:

- Patients who have had more than two prior chemotherapeutic regimens.

- Patients who have had prior treatment with Pemetrexed.

- Patients with a GOG performance status of 3 or 4.

- Patients with ≥ grade 2 neuropathy.

- Patients who have received external beam whole pelvic or whole abdominal radiation treatment (≥ 4500cGy) which would limit vascular capacity and reduce adequate drug delivery.

- Patients with evidence of recurrence from another malignancy within the previous five years.

- Patients with a concomitant malignancy other than squamous cell skin cancer.

- Patients with uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, unstable angina pectoris, or psychiatric illness / social situations that would limit compliance with study requirements.

- Patients who have received an investigational drug within the last 30 days that has not received regulatory approval.

- Presence of third space fluid which cannot be controlled by drainage.
Location
Montefiore Medical Center
Bronx, New York, United States
Status: Recruiting
Contact: Loraine Centrilla, RN - 718-405-8082 - lcentril@montefiore.org
Start Date
April 2008
Completion Date
April 2014
Sponsors
Montefiore Medical Center
Source
Montefiore Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page