Clinical trial NCT00047632 (phase 3, status: terminated)
Conditions: ovarian carcinoma, peritoneal carcinoma
ICD codes: C22.0, C22.1, C4A.9, C7B.1, D09.9, C4A.0, C4A.31
Drugs: interferon gamma-1b
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Reason stopped: 
    futility
  
Eligibility criteria:

        Inclusion criteria:

          -  Histologically confirmed epithelial ovarian or primary peritoneal carcinoma, FIGO
             Stage III or IV disease. Patients with either optimal (<= 1 cm residual disease) or
             suboptimal residual disease following initial surgery are eligible. Unstained slides
             of the primary tumor, a primary tumor block, or cytological preparation must be
             available for review.

          -  Patients with the following histologic epithelial cell types are eligible: serous
             adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated
             carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, transitional cell
             carcinoma, malignant Brenner's Tumor, or adenocarcinoma N.O.S.

          -  <= 12 weeks after initial surgery with adequate recovery from surgery.

          -  Candidate for first-line chemotherapy

          -  Adequate bone marrow function (ANC >= 1,500/mL; platelets >= 100,000/mL; hemoglobin >=
             10 gm/dL)

          -  Adequate hepatic function (AST, ALT, and alkaline phosphatase <= 2.5 x upper limit of
             normal; bilirubin <= 1.5 x upper limit of normal).

          -  Adequate renal function (creatinine <= 1.5 x upper limit of normal).

          -  Adequate neurologic function (sensory and motor neuropathy <= NCI CTC Grade 1).

          -  Negative urine pregnancy test in women of child-bearing potential (within 14 days of
             the initiation of the first chemotherapy cycle).

          -  Zubrod / ECOG / GOG performance score 0-2.

          -  Able to give informed consent.

        Exclusion criteria:

          -  Epithelial ovarian tumors of low malignant potential (borderline carcinomas). If
             diagnosis is based on cytology alone [(e.g., fine needle aspiration (FNA)], slides
             must be available, and confounding carcinomas such as non-ovarian mucinous,
             colorectal, Fallopian tube, and other adenocarcinomas of non-ovarian origin must be
             ruled out.

          -  Prior therapy for ovarian or primary peritoneal carcinoma other than primary surgical
             debulking.

          -  Patients for whom therapy for ovarian or primary peritoneal carcinoma in addition to
             protocol therapy is planned.

          -  Prior biological response modifier (BRM) for any reason within the previous 5 years.

          -  Prior malignancy within the previous 5 years other than basal cell or squamous cell
             carcinomas or in situ carcinoma of the cervix. Patients who have had a malignancy > 5
             years previously may be eligible for this trial if they have not received any
             anti-neoplastic treatment within the previous 5 years an dif they have been without
             any evidence of disease for the previous 5 years.

          -  Uncontrolled infection.

          -  Pregnant or nursing women are excluded. Women of child-bearing potential must agree to
             use a chemical or barrier contraceptive during the dosing portion of the study.

          -  Any illness or condition that in the opinion of the investigator may affect safety of
             treatment or evaluation of any of the study's endpoints.