Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma
- 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.
- 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
- Patients with evidence of recurrence from another malignancy within the previous five
- 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.