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Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma

Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Peritoneal Cancer, Fallopian Tube Cancer

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Trial Information

Phase II Trial of Combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in Platinum Sensitive Recurrent Ovarian, Primary Peritoneal, and Fallopian Tube Carcinoma

- 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.

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To evaluate the response rate of combination Pemetrexed (Alimta) and Carboplatin (Paraplatin) in recurrent ovarian, primary peritoneal, and fallopian tube carcinoma.

Outcome Time Frame:

2 years

Safety Issue:


Principal Investigator

Dennis Yi-Shin Kuo, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center


United States: Institutional Review Board

Study ID:




Start Date:

April 2008

Completion Date:

April 2014

Related Keywords:

  • Ovarian Cancer
  • Peritoneal Cancer
  • Fallopian Tube Cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Montefiore Medical CenterBronx, New York  10467-2490