Clinical trial · Interventional
Cetuximab, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer
A Phase I Trial of Tailored Radiation Therapy With Concomitant Cetuximab (C225, NSC #714692) and Cisplatin (NSC #119875) in the Treatment of Patients With Cervical 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)
This phase I trial is studying the side effects and best dose of cetuximab when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. Giving cetuximab together with cisplatin and radiation therapy may kill more tumor cells.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Adenocarcinoma | Cervical Adenocarcinoma | CURATED_BROADER | 0.80 |
| Cervical Adenosquamous Carcinoma | Cervical Adenosquamous Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Cervical Small Cell Carcinoma | Cervical Small Cell Neuroendocrine Carcinoma | ALIAS | 0.90 |
| Cervical Squamous Cell Carcinoma | Cervical Squamous Cell Carcinoma | CURATED_BROADER | 0.80 |
| Stage IB Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIA Cervical Cancer | Malignant Cervical Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Cervical Cancer | Malignant Cervical Neoplasm |
Interventions
Interventions (4)
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Treatment (brachytherapy, radiation, cetuximab, cisplatin)
- description
- Patients receive cetuximab IV over 1-2 hours and cisplatin IV on days 1, 8, 15, 22, 29, and 36 (weeks 1-6). Patients also undergo external beam radiotherapy to the para-aortic and pelvic lymph nodes OR whole pelvis once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33 (weeks 1-5). Patients then receive either 1 or 2 applications of low-dose rate brachytherapy in weeks 6-8 OR 5 applications of high-dose rate (HDR)\* brachytherapy once weekly in weeks 4-8. Treatment continues in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: Internal Radiation Therapy
- Radiation: 3-Dimensional Conformal Radiation Therapy
- Biological: Cetuximab
- Drug: Cisplatin
Primary outcomes (2)
- measure
- Maximum tolerated dose (MTD) or biologically effective dose (BED) of Cetuximab in combination with cisplatin and extended field radiation or whole pelvis radiation, graded using Common Terminology Criteria for Adverse Events version 3.0 (CTCAE v3.0)
- timeFrame
- 6 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed cervical cancer * Clinical stage IB-IVA disease * Any cell type allowed * Positive or negative pelvic and/or para-aortic lymph nodes by radiography * Unstained sections from primary tumor available * Performance status - GOG 0-1 * 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 normal * Creatinine clearance \> 50 mL/min * Patients with ureteral obstruction must undergo stent or nephrostomy tube placement prior to study entry * No renal abnormality (e.g., pelvic kidney or horseshoe kidney) that would require modification of radiation fields * No significant cardiac disease within the past 6 months, including any of the following: * Uncontrolled hypertension * Unstable angina * Congestive heart failure * Uncontrolled arrhythmia * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No sensory or motor neuropathy \> grade 1 * No septicemia * No severe infection * No circumstance that would preclude study participation or follow-up * No other invasive malignancy within the past 5 years except nonmelanoma skin cancer * No uncontrolled seizure disorder * No active neurologic disease * No history of active collagen vascular disease * No prior chimerized or murine monoclonal antibody therapy * No prior cytotoxic chemotherapy for cervical cancer * No prior pelvic or abdominal radiotherapy for cervical cancer * No concurrent intensity modulated radiotherapy * No prior renal transplantation * More than 30 days since prior major surgery (excluding diagnostic biopsy) * No other prior therapy for cervical cancer * No prior cancer treatment that would preclude study therapy * No other concurrent investigational agents
References
Publications (0)
Data not yet available