Phase II Study in Patients With Epidermal Growth Factor Receptor (EGFR) + Advanced Stage Ovarian, Primary Peritoneal and Fallopian Tube Cancer

NCT ID: NCT00063401

Last Updated: 2010-04-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-09-30
• Study Completion Date: 2006-06-30

Brief Summary

The purpose of this study is to determine the progression-free survival obtained with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.

Detailed Description

The population being studied in this trial is subjects with advanced stage ovarian, primary peritoneal and fallopian tube cancer will be enrolled. By receiving combination therapy with cetuximab (C225)/paclitaxel/carboplatin, these subjects will experience longer progression-free survival than previously reported for subjects receiving only paclitaxel and carboplatin.

Conditions

Ovarian Cancer; Peritoneal Neoplasms; Fallopian Tube Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Cetuximab 400 mg/m2 IV (over 120 minutes) on Day 1 of Cycle 1, followed by weekly maintenance doses of 250 mg/m2 IV (over 60 minutes). Paclitaxel 175 mg/m2 IC (over 3 hours) and carboplatin AUC of 6 IV (over 30 minutes) on Day 1 of each cycle. For eligible subjects, maintenance therapy will consist of cetuximab 250 mg/m2/week for up to 6 months.

Group Type: EXPERIMENTAL

Cetuximab:

Intervention Type: BIOLOGICAL

400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles

Paclitaxel

Intervention Type: DRUG

175 mg/m2 Day 1, six 21-day cycles

Carboplatin

Intervention Type: DRUG

AUC = 6 Day1, six 21-day cycles

Interventions

Cetuximab:

400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles

Intervention Type: BIOLOGICAL

Paclitaxel

175 mg/m2 Day 1, six 21-day cycles

Intervention Type: DRUG

Carboplatin

AUC = 6 Day1, six 21-day cycles

Intervention Type: DRUG

Other Intervention Names

Erbitux

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

ImClone LLC

Principal Investigators

E-mail: ClinicalTrials@ ImClone.com

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

ImClone Investigational Site

New York, New York, United States

ImClone Investigational Site

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

CA225-009

Identifier Type: -

Identifier Source: org_study_id

NCT00070044

Identifier Type: -

Identifier Source: nct_alias