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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00063401
• Other study ID #: CA225-009
• Status: Completed
• Phase: Phase 2
• First received: June 25, 2003
• Last updated: April 7, 2010
• Start date: September 2003
• Est. completion date: June 2006

Study information

• Verified date: April 2010
• Source: ImClone LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00070044

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: June 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fallopian Tube Neoplasms
• Neoplasms
• Ovarian Cancer
• Peritoneal Neoplasms

Intervention

Biological:
• Cetuximab:
400 mg/m2 loading dose, 250 mg/m2 weekly, six 21-day cycles

Drug:
• Paclitaxel
175 mg/m2 Day 1, six 21-day cycles
• Carboplatin
AUC = 6 Day1, six 21-day cycles

Locations

Country	Name	City	State
United States	ImClone Investigational Site	New York	New York
United States	ImClone Investigational Site	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
ImClone LLC	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		How long patients have progression-free survival	No
Secondary	To determine clinical and/or pathological response rates with cetuximab (C225)/paclitaxel/carboplatin in subjects with newly diagnosed advanced stage ovarian, primary peritoneal, or fallopian tube cancer.		Length of time for a response to treatment	No
Secondary	To evaluate the toxicity of the combination regimen in this subject population.		Length of time for a response to treatment	Yes
Secondary	To access EGFR expression by immunohistochemical assay.		Length of time for a response to treatment	Yes