Clinical trial · Interventional
Paclitaxel, Cisplatin, and Filgrastim Combined With Radiation Therapy in Treating Patients With Locally Recurrent Head and Neck Cancer
Phase II Study of Paclitaxel and Cisplatin in Combination With Split Course Concomitant Hyperfractionated Re-Irradiation in Patients With Recurrent Squamous Cell Cancer of the Head and Neck
- 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: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors such as filgrastim may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system recover from the side effects of chemotherapy. Radiation therapy uses high-energy x-rays to damage tumor cells. PURPOSE: Phase II trial to study the effectiveness of paclitaxel, cisplatin, and filgrastim combined with radiation therapy in treating patients who have locally recurrent head and neck cancer and have received previous treatment with radiation therapy.
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 |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cisplatin | Drug | Cisplatin | ALIAS |
| conventional surgery | Procedure | — | UNRESOLVED |
| filgrastim | Biological | Filgrastim | ALIAS |
| paclitaxel | Drug | Paclitaxel | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Radiation (BID) and chemotherapy
- description
- Radiation (BID), cisplatin and paclitaxel given on days 1-5 (Monday-Friday) in weeks 1, 3, 5 and 7. G-CSF given on days 6-13.
- interventionNames
- Biological: filgrastim
- Drug: cisplatin
- Drug: paclitaxel
- Procedure: conventional surgery
- Radiation: radiation therapy
Primary outcomes (1)
- measure
- Overall Survival
- timeFrame
- From registration to 1 year
Secondary outcomes (3)
- measure
- Disease-free Survival
- timeFrame
- From registration to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically proven locally recurrent primary squamous cell cancer (SCC) of the head and neck or second primary SCC of the head and neck * More than 1 prior recurrence allowed if the first recurrence occurred at least 6 months after completion of prior radiotherapy * Disease must be confined to the head and neck (above the clavicles) * No primary SCC of the nasopharynx or salivary gland * Prior irradiation of 45-75 Gy to the majority (75% or greater) of tumor volume * Entire tumor volume must be included in a treatment field that limits the total spinal cord dose (prior and anticipated) to 50 Gy * Prior radiotherapy records, including simulation and portal films, available in order to assure that cord tolerance is not exceeded * Measurable disease * Ineligible for complete surgical resection * No distant metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * Zubrod 0 or 1 Life expectancy: * No other concurrent illness that would limit survival Hematopoietic: * Granulocyte count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * Serum glutamate oxaloacetate transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) no greater than 2 times normal\* * Alkaline phosphatase no greater than 2 times normal\* * \* Greater than 2 times normal allowed if no metastases by liver ultrasound or CT scan Renal: * Creatinine no greater than 1.5 mg/dL Other: * No other invasive malignancy within the past 2 years except in situ malignancies (e.g., carcinoma in situ of the cervix, carcinoma in situ of the breast, or nonmelanoma skin cancer) * No other concurrent illness that would impair tolerance to therapy * No grade 2 or worse pre-existing peripheral sensory neuropathy * No hypersensitivity to E. coli derived products * Not pregnant or nursing * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Prior chemotherapy allowed as a component of the primary treatment * No prior chemotherapy for recurrent disease * At least 6 months since prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 6 months since prior radiotherapy Surgery: * See Disease Characteristics
References
Publications (4)
- RESULTLanger CJ, Harris J, Horwitz EM, Nicolaou N, Kies M, Curran W, Wong S, Ang K. Phase II study of low-dose paclitaxel and cisplatin in combination with split-course concomitant twice-daily reirradiation in recurrent squamous cell carcinoma of the head and neck: results of Radiation Therapy Oncology Group Protocol 9911. J Clin Oncol. 2007 Oct 20;25(30):4800-5. doi: 10.1200/JCO.2006.07.9194. PMID 17947728
- RESULTHorwitz EM, Harris J, Langer CJ, et al.: Concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): update of RTOG 9911 . [Abstract] J Clin Oncol 23 (Suppl 16): A-5577, 519s, 2005.
- RESULTHorwitz EM, Harris J, Langer CJ, et al.: Phase II study of paclitaxel and cisplatin in combination with split course concomitant hyperfractioned re-irradiation in patients with recurrent squamous cell cancer of the head and neck : results of RTOG 99-11. [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-119, S72, 2005.
- RESULTLanger CJ, Harris J, Horwitz E, et al.: Phase II trial of concurrent split course hyperfractionated radiotherapy (Hfx RT), cisplatin (DDP) and paclitaxel (P) in patients with recurrent, previously irradiated squamous cell carcinoma of the head and neck (SCCHN): results of RTOG 9911. [Abstract] J Clin Oncol 22 (Suppl 14): A-5509, 490s, 2004.