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A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer

Phase 2
18 Years
Not Enrolling
Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Phase II Evaluation of Cetuximab (C225, NSC #714692) in Combination With Carboplatin (NSC #241240) in the Treatment of Recurrent Platinum-Sensitive Ovarian or Primary Peritoneal Cancer


- Determine the antitumor activity of cetuximab and carboplatin in patients with
recurrent platinum-sensitive ovarian epithelial or primary peritoneal cancer.

- Determine the nature and degree of toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive cetuximab IV over 1 hour (over 2 hours on day 1 of course 1 only) on days
1, 8 , and 15. Patients also receive carboplatin IV after cetuximab administration on day 1.
Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 20-65 patients will be accrued for this study.

Inclusion Criteria


- Histologically confirmed ovarian epithelial or primary peritoneal cancer

- Recurrent disease

- Measurable disease

- At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional
techniques, including palpation, plain x-ray, CT scan, or MRI OR ≥ 10 mm by
spiral CT scan

- Target lesion not within previously irradiated field

- Received 1 prior platinum-based chemotherapy regimen for primary disease containing
carboplatin, cisplatin, or other organoplatinum compound

- Initial treatment may have included high-dose, consolidation, or extended
therapy administered after surgical or non-surgical assessment

- Patients who had not received prior paclitaxel therapy may have received a
second regimen that included paclitaxel

- Platinum-sensitive disease

- Treatment-free interval without clinical evidence of progressive disease for
more than 6 months after response to a prior platinum-based regimen

- If there is another concurrently active GOG-0146 series protocol
(non-platinum-based therapy), must have had a treatment-free interval of more
than 12 months unless ineligible for the other protocol* NOTE: *Applies whether
or not both protocols are available at the same participating center

- Must have available tissue block or unstained sections from primary tumor, interval
debulking, or secondary debulking

- Not eligible for a higher priority GOG protocol (i.e., any active phase III GOG
protocol for the same patient population)



- 18 and over

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ 1.5 times ULN


- No uncontrolled hypertension

- No unstable angina

- No congestive heart failure

- No uncontrolled arrhythmias within the past 6 months

- No other significant cardiac disease


- No uncontrolled seizure disorder

- No active neurological disease

- No neuropathy > grade 1


- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- No active infection requiring antibiotics

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception


Biologic therapy

- No prior anti-epidermal growth factor receptor (EGFR) antibody therapy

- No prior chimerized or murine monoclonal antibody therapy

- At least 3 weeks since prior biologic or immunologic therapy for the malignancy


- See Disease Characteristics

- Recovered from prior chemotherapy

- No prior cytotoxic chemotherapy for recurrent disease, including retreatment with
initial chemotherapy regimens

Endocrine therapy

- At least 1 week since prior hormonal therapy for the malignancy

- Concurrent hormone replacement therapy allowed


- See Disease Characteristics

- Recovered from prior radiotherapy

- No prior radiotherapy to > 25% of bone marrow-bearing areas


- More than 30 days since prior major surgery and recovered

- Diagnostic biopsy not considered major surgery


- At least 3 weeks since other prior therapy for the malignancy

- No prior tyrosine kinase inhibitors that target the EGFR pathway

- No prior cancer treatment that would preclude study treatment

- No other concurrent investigational agents

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Principal Investigator

Angeles A. Secord, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Duke Cancer Institute


United States: Federal Government

Study ID:




Start Date:

June 2004

Completion Date:

Related Keywords:

  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • recurrent ovarian epithelial cancer
  • primary peritoneal cavity cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Neoplasms, Glandular and Epithelial



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