Clinical trial NCT00063401 (phase 2, status: completed)
Conditions: ovarian cancer, peritoneal neoplasms, fallopian tube neoplasms
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: paclitaxel, carboplatin
SMILES: [H][C@@]1(C[C@@H](C)[C@]2([H])CC(=O)[C@H](C)\C=C(C)\[C@@H](O)[C@@H](OC)C(=O)[C@H](C)C[C@H](C)\C=C\C=C\C=C(C)\[C@H](C[C@]3([H])CC[C@@H](C)[C@@](O)(O3)C(=O)C(=O)N3CCCC[C@@]3([H])C(=O)O2)OC)CC[C@@H](OCCO)[C@@H](C1)OC, N[C@@H](CCCNC(N)=N)C(O)=O
Eligibility criteria:

        Inclusion Criteria

          1. Subjects must have signed an approved informed consent.

          2. Subjects with histologic diagnosis of epithelial ovarian carcinoma, primary peritoneal
             carcinoma, or fallopian tube carcinoma, Stage III or IV, with either optimal (≤ 1 cm
             residual disease) or suboptimal residual disease following initial surgery. All
             subjects must have had appropriate surgery for ovarian, primary peritoneal, or
             fallopian tube carcinoma with appropriate tissue available for histologic evaluation.
             Pathology must be verified at the participating institution

          3. Subjects 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.

          4. Subjects with tumor tissue available for assessment of EGFR status by IHC.

          5. EGFR expression must be positive (e.g., 1+).

          6. Subjects must have a Karnofsky Performance Status (KPS) of ≥ 70%.

          7. Subjects must be entered no more than 12 weeks postoperatively.

          8. Women, ages 18 and older.

          9. Bone marrow function: absolute neutrophil count (ANC) ≥ 1,500/ul, equivalent to Common
             Toxicity Criteria (CTC) grade 1. Platelets ≥ the institutional lower limit of normal
             (LLN), CTC grade 0.

         10. Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN), CTC
             grade 1.

         11. Hepatic function: bilirubin ≤ 1.5 x ULN, CTC grade 1. AST ≤ 2.5 x ULN, CTC grade 1.

         12. Neurologic function: neuropathy (sensory) ≤ CTC grade 1.

        Exclusion Criteria

          1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for
             the entire study period and for up to 4 weeks after the study.

          2. WOCBP using a prohibited contraceptive method.

          3. Women who are pregnant or breastfeeding

          4. Women with a positive pregnancy test on enrollment or prior to study drug
             administration.

          5. Subjects with a current diagnosis of epithelial ovarian tumor of low malignant
             potential (borderline carcinomas) are not eligible. Subjects with a prior diagnosis of
             a low malignant potential tumor that was surgically resected and who subsequently
             develop invasive adenocarcinoma are eligible, provided that they have not received
             prior chemotherapy for any ovarian tumor.

          6. Subjects who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis are excluded. Prior radiation for localized cancer of the breast, head and
             neck, or skin is permitted, provided that it was completed more than 3 years prior to
             registration, and the subject remains free of recurrent or metastatic disease.

          7. Subjects who have received prior chemotherapy for any abdominal or pelvic tumor are
             excluded. Subjects may have received prior adjuvant chemotherapy for localized breast
             cancer, provided that it was completed more than 3 years prior to registration,and
             that the subject remains free of recurrent or metastatic disease.

          8. With the exception of non-melanoma skin cancer and other specific malignancies as
             noted above, subjects with other invasive malignancies who had (or have) any evidence
             of the other cancer present within the last 5 years or whose previous cancer treatment
             contraindicates this protocol therapy are excluded.

          9. Subjects with acute hepatitis.

         10. Subjects with active or uncontrolled infection are not eligible.

         11. Subjects with a significant history of cardiac disease, i.e., uncontrolled
             hypertension,unstable angina, and congestive heart failure.

         12. Subjects with left ventricular ejection fraction (LVEF) below the institutional range
             of normal on a baseline multiple gated acquisition (MUGA) scan or echocardiogram.

         13. A history of prior cetuximab or other therapy which targets the EGFR pathway or a
             history of prior chimerized or murine monoclonal antibody therapy.

         14. Subjects with a known allergy to murine proteins or Cremophor EL.