Clinical trial NCT00230542 (phase 2, status: completed)
Conditions: ovarian cancer, peritoneal cancer, fallopian tube cancer
ICD codes: C05.2, C10.0, C16.0, C16.4, C17.0, C17.1, C17.2, K65.1, K66.0, N99.4, N73.6, R88.0, Z49.32, Z49.02, C57.00, C57.01, C57.02
Drugs: carboplatin, pemetrexed
SMILES: N[C@@H](CCCNC(N)=N)C(O)=O, [H][N]([H])([H])[Pt](Cl)(Cl)[N]([H])([H])[H]
Eligibility criteria:

        Inclusion Criteria:

          -  Diagnosis of 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.

          -  At least one measurable lesion according to RECIST criteria via CT or MRI scan

          -  Received a platinum-containing regimen at initial diagnosis

          -  ECOG performance status of 0,1 or 2

          -  18 years of age or older

          -  Life expectancy of greater than 12 weeks

          -  WBC > 1,500/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)

          -  Complete recovery from completion of previous chemotherapy or biologic therapy

          -  Negative pregnancy test and agree to practice effective method of birth control

        Exclusion Criteria:

          -  Patients with sarcomatous, stromal, or germ cell elements

          -  Prior pelvic radiotherapy > 25% of bone marrow

          -  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

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

          -  Prior malignancy except 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) of which the patient has been
             disease-free for at least five years

          -  Routine prophylactic use of G-CSF or GM-CSF or blood transfusions within 2 weeks

          -  Clinically significant cardiac disease as defined by: history of unstable angina
             within 6 months; history of symptomatic ventricular arrhythmias; history of congestive
             heart failure; history of myocardial infarction within 6 months

          -  Uncontrolled hypercalcemia or diabetes mellitus

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

          -  Grade 2 or greater peripheral neuropathy

          -  Participation in an investigational study within three weeks

          -  History of anaphylactic shock to prior platinum chemotherapy

          -  History of psychiatric disability or other central nervous system disorder