Clinical trial · Interventional
Cetuximab and Carboplatin in Treating Patients With Recurrent Ovarian Epithelial Cancer or Primary Peritoneal Cancer
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Primary Peritoneal Cavity Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| carboplatin | Drug | Carboplatin | ALIAS |
| cetuximab | Biological | Cetuximab | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- RESULTSecord AA, Blessing JA, Armstrong DK, Rodgers WH, Miner Z, Barnes MN, Lewandowski G, Mannel RS; Gynecologic Oncology Group. Phase II trial of cetuximab and carboplatin in relapsed platinum-sensitive ovarian cancer and evaluation of epidermal growth factor receptor expression: a Gynecologic Oncology Group study. Gynecol Oncol. 2008 Mar;108(3):493-9. doi: 10.1016/j.ygyno.2007.11.029. Epub 2008 Jan 14. PMID 18191993