Clinical trial · Interventional
Erlotinib, Cisplatin, and Radiation Therapy in Treating Patients With Stage IB-Stage IVA Cervical Cancer
Erlotinib in Combination With Cisplatin as Radiosensitizing Agents in Women Receiving Radiation Therapy for Locally Advanced Squamous Cell Carcinoma of the Cervix; A Phase I Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Withdrawn due to lack of accrual
Summary
Brief summary (as posted)
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 to kill tumor cells. Erlotinib and cisplatin may make tumor cells more sensitive to radiation therapy. Giving erlotinib together with cisplatin and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of erlotinib when given together with cisplatin and radiation therapy in treating patients with stage IB, stage II, stage III, or stage IVA cervical cancer.
Conditions
Conditions (1)
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 Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| radiation therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cohort 1
- description
- Erlotinib 100 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
- interventionNames
- Drug: cisplatin
- Drug: erlotinib hydrochloride
- Procedure: radiation therapy
- type
- EXPERIMENTAL
- label
- Cohort 2
- description
- Erlotinib 125 mg/day by mouth beginning on day 1 of radiotherapy (RT) and cisplatin dosing (40 mg/m\^2 intravenous every 7 days during RT) and continuing daily through radiation
- interventionNames
- Drug: cisplatin
- Drug: erlotinib hydrochloride
- Procedure: radiation therapy
- type
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of squamous cell carcinoma of the cervix * Stage IB-IVA disease * Scheduled to undergo standard radiotherapy and receive weekly cisplatin * ECOG performance status 0-2 * Not pregnant * Negative pregnancy test * Fertile patients must use effective contraception during and for ≥ 1 week after completion of study treatment * Must be able to take oral medication Exclusion Criteria: * Malabsorption syndrome * Serious underlying medical condition that would impair the ability of patient to receive treatment * Known hypersensitivity to erlotinib hydrochloride * Psychological, familial, sociological, or geographical conditions that would preclude study compliance * Less than 21 days since prior nonapproved or investigational drugs * Prior chemotherapy * Prior radiotherapy * Prior anti-epidermal growth factor receptor treatment * Prior gastrointestinal surgery that limits absorption (i.e., requiring total parenteral nutrition) * Concurrent use of any of the following agents and therapies: * Other antineoplastic or antitumor agents * Other chemotherapy * Other investigational agents * Radiotherapy * Immunotherapy * Anticancer hormonal therapy
References
Publications (0)
Data not yet available