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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

Thank you

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 Center Bronx, New York  10467-2490