A Phase II Study of Cetuximab (C225)/Paclitaxel/Carboplatin for the Initial Treatment of Advanced Stage Ovarian, Primary Peritoneal, and Fallopian Tube Cancer
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
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.
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
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.