Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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Purpose
RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy such as carboplatin work in different ways to stop tumor cells from dividing so they stop growing or die. Combining cetuximab with carboplatin may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving cetuximab together with carboplatin works in treating patients with recurrent ovarian epithelial cancer or primary peritoneal cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Ovarian Cancer Primary Peritoneal Cavity Cancer |
Biological: cetuximab Drug: carboplatin |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 |
| Study Start Date: | June 2004 |
| Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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)
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- GOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
Hepatic
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- SGOT ≤ 2.5 times ULN
- Alkaline phosphatase ≤ 2.5 times ULN
Renal
- Creatinine ≤ 1.5 times ULN
Cardiovascular
- No uncontrolled hypertension
- No unstable angina
- No congestive heart failure
- No uncontrolled arrhythmias within the past 6 months
- No other significant cardiac disease
Neurologic
- No uncontrolled seizure disorder
- No active neurological disease
- No neuropathy > grade 1
Other
- 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
PRIOR CONCURRENT THERAPY:
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
Chemotherapy
- 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
Radiotherapy
- See Disease Characteristics
- Recovered from prior radiotherapy
- No prior radiotherapy to > 25% of bone marrow-bearing areas
Surgery
More than 30 days since prior major surgery and recovered
- Diagnostic biopsy not considered major surgery
Other
- 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
Contacts and Locations
Show 76 Study Locations| Study Chair: | Angeles A. Secord, MD | Duke Cancer Institute |
| Investigator: | Deborah K. Armstrong, MD | Sidney Kimmel Comprehensive Cancer Center |
| Investigator: | Nita Maihle, PhD | Yale University |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00086892 History of Changes |
| Other Study ID Numbers: | CDR0000371712, GOG-0146P, BMS-CA225-019 |
| Study First Received: | July 8, 2004 |
| Last Updated: | December 13, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
recurrent ovarian epithelial cancer primary peritoneal cavity cancer |
Additional relevant MeSH terms:
|
Ovarian Neoplasms Peritoneal Neoplasms Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases |
Gonadal Disorders Abdominal Neoplasms Digestive System Neoplasms Digestive System Diseases Peritoneal Diseases Neoplasms by Histologic Type Cetuximab Carboplatin Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013