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Phase I/II Study of Carboplatin and Pralatrexate in Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

Phase 1/Phase 2
18 Years
Open (Enrolling)
Ovarian Cancer, Fallopian Tube Cancer, Peritoneal Cancer

Thank you

Trial Information

Phase I/II Study of Carboplatin and Pralatrexate in Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian or Primary Peritoneal Cancer

- Since we are looking for the highest dose of the study drug that can be administered
safely without severe or unmanageable side effects, not everyone who participates will
receive the same dose of the study drug.

- Each study cycle will last 28 days. On Day 1, participants will receive carboplatin
intravenously. On Days 1 and 15 of each cycle they will receive pralatrexate
intravenously. Participants will also be asked to take folic acid orally on a daily
basis starting 7 days before the first dose of pralatrexate and continuing until 30
days after the last dose of pralatrexate. They will also receive a vitamin B12
injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10
weeks after the first dose of pralatrexate.

- Participants will come to the clinic on Day 1 and 15 of each cycle and have the
following tests/procedures performed: Medical history; Vital signs; Blood tests,
assessment of the tumor (every two cycles) and an EKG (before the start of cycle 2).

- In addition, during Cycle 1, participants will come to the clinic weekly for blood

- Pharmacokinetic (PK) blood samples (to monitor how the body absorbs and breaks down the
study drug) will be done at the following time points during Cycle 1: Day 1-3 and Day

- Participants will be asked to take the study drugs for up to 6 cycles. They may
continue beyond 6 cycles as long as there is evidence that the tumor is not growing and
they are not experiencing any unacceptable side effects.

Inclusion Criteria:

- Patients must be diagnosed with a 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.

- Patients must have at least one measurable lesion according to RECIST criteria via CT
or MRI scan. CT of the chest should be performed if any known disease is present in
the chest. Pleural effusions, ascites, bone metastases, CA125 tumor markers, and
lesions located in previously radiated areas are not considered measurable.

- Patients must have received a platinum-containing regimen at initial diagnosis.

- ECOG Performance Status of 0, 1 or 2

- Patients may have received up to 2 prior chemotherapy regimens in the recurrent
cancer setting

- 18 years of age or older

- Life expectancy of greater than 12 weeks

- Baseline laboratory values must meet what is outlined in the protocol

- Patients must receive vitamin B12 and folic acid prior to starting treatment

- Complete recovery from previous chemotherapy or biologic therapy

- During the Phase II of the study, patients with significant ascites and/or pleural
effusions will undergo consideration of drainage of these areas prior to starting
carboplatin and pralatrexate.

- Women of childbearing potential must have a negative pregnancy test within 7 days
prior to initiating chemotherapy on trial and must agree to practice effective method
of birth control during the study and for six months after their last treatment.

- Patients must have a normal QTc interval

Exclusion Criteria:

- Prior pelvic radiotherapy to greater than 25% of bone marrow

- Any 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

- Patient with known history of CNS metastasis is ineligible unless the patient has had
treatment with surgery or radiation therapy, is neurologically stable, and does not
require oral or intravenous corticosteroids or anticonvulsants.

- A history of prior malignancy except for 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) for which the
patient has been disease-free for at least three years.

- Routine prophylactic use of G-CSF or GM-CSF within two weeks prior to study entry.

- Clinically significant cardiac disease

- Uncontrolled hypercalcemia or diabetes mellitus

- Any signs of intestinal obstruction that interfere with bowel function and/or

- Grade 2 or greater peripheral neuropathy

- Participation in an investigational study within three weeks prior to study entry.

- History of anaphylactic shock to prior platinum chemotherapy that would preclude safe
administration of study carboplatin.

- History of psychiatric disability or other central nervous system disorder as judged
by the principal investigator that would be considered significant and that would
preclude informed consent, safe administration of study medications and affecting
ability to comply with study procedures.

- Doses of ibuprofen in excess of 400mg QID.

- Interval cytoreductive surgery planned for while subject is on-study.

- Recurrence/progression within 6 months of receiving ay platinum regimen

- Patients with either pleural effusions or ascites are not eligible for Phase I of the

Type of Study:


Study Design:

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

Outcome Measure:

Maximum Tolerated Dose

Outcome Description:

To identify the maximum tolerated dose of Pralatrexate in combination with carboplatin in this patient population.

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Marcela G. del Carmen, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital


United States: Institutional Review Board

Study ID:




Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Cancer
  • carboplatin
  • recurrent
  • platinum sensitive
  • pralatrexate
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617