Chemotherapy Followed by Surgery, Chemotherapy, and Radiation Therapy in Treating Patients With Locally Advanced Head And Neck Cancer

NCT00544414 | Completed Phase 2 Results

• 4 other identifiers: 98147P30CA033572CHNMC-98147CDR0000566884
• Study Type: interventional
• Target: 31
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving combination chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs such as gemcitabine and cisplatin may make tumor cells more sensitive to radiation therapy. Giving combination chemotherapy before surgery or radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving chemotherapy followed by surgery, chemotherapy, and radiation therapy works in treating patients with locally advanced head and neck cancer.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage II squamous cell carcinoma of the larynx; stage II squamous cell carcinoma of the hypopharynx; stage II squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (2)

• Overall Response

  Complete response (CR): Complete disappearance of all measurable and evaluable disease. No new lesions. Partial response (PR): Greater than or equal 50% decrease under baseline in the sum of products of perpendicular diameters of all measurable lesions. No new lesions. All measurable and evaluable lesions and sites must be assessed using the same techniques as baseline. Overall Response (OR) = CR + PR.

  30 days after last course of treatment

• Progression-free Survival

  Estimated using the product-limit method of Kaplan and Meier. Progression defined as a 50% increase or an increase of 10 cm\^2 (whichever is smaller) in the sum of all measurable lesions over smallest sum observed (over baseline if no decrease) using the same techniques as baseline, or clear worsening of any evaluable disease, or reappearance of any lesion that had disappeared, or appearance of any new lesion/site, or failure to return for evaluation due to death or deteriorating condition. Progression-free survival defined as from first day of treatment until the date of first documented progression or date of death from any cause, whichever came first. If failure has not occurred, failure time is censored at the time of last follow-up.

  From date of initial treatment until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 171 months

Study Arms (1)

Treatment

EXPERIMENTAL

Patients receive neoadjuvant induction chemotherapy comprising docetaxel IV over 1 hour on day 1 and cisplatin IV, leucovorin IV, and fluorouracil IV over 24 hours on days 1-4. Induction chemotherapy repeats every 28 days for 3 courses. Patients with partial response at the primary site may undergo radical or functional resection of the primary tumor within 3 weeks of completion of neoadjuvant therapy. Beginning within 4 weeks of completion of neoadjuvant therapy, patients with persistent disease or complete response after chemotherapy at the primary or neck then undergo radiotherapy 5 days a week for 7 weeks and receive gemcitabine hydrochloride IV over 30 minutes and cisplatin IV over 60 minutes on day 1 of each week of radiotherapy.

Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil; Drug: gemcitabine hydrochloride; Drug: leucovorin calcium; Genetic: gene expression analysis; Genetic: protein expression analysis; Other: laboratory biomarker analysis; Procedure: adjuvant therapy; Procedure: biopsy; Procedure: conventional surgery; Procedure: neoadjuvant therapy; Procedure: quality-of-life assessment; Radiation: radiation therapy

Interventions

cisplatin DRUG

Treatment

docetaxel DRUG

Treatment

fluorouracil DRUG

Treatment

gemcitabine hydrochloride DRUG

Treatment

leucovorin calcium DRUG

Treatment

gene expression analysis GENETIC

Treatment

protein expression analysis GENETIC

Treatment

laboratory biomarker analysis OTHER

Treatment

adjuvant therapy PROCEDURE

Treatment

biopsy PROCEDURE

Treatment

conventional surgery PROCEDURE

Treatment

neoadjuvant therapy PROCEDURE

Treatment

quality-of-life assessment PROCEDURE

Treatment

radiation therapy RADIATION

Treatment

Eligibility Criteria

• Age: 0 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed squamous cell carcinoma of the head and neck, including any of the following subtypes: * Oral cavity * Oropharynx * Hypopharynx * Larynx * Stage III or IV disease * Stage II carcinoma of the larynx, hypopharynx, or base of tongue allowed * Measurable disease * Resectable disease, defined as tumors that are potentially curable by surgery and radiotherapy PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 60% * ANC ≥ 1,500/μL * Platelet count ≥ 100,000/μL * Creatinine ≤ 1.5 mg/dL OR creatinine clearance \> 60 mL/min * Bilirubin ≤ 1.5 mg/dL * Transaminases and alkaline phosphatase meeting 1 of the following criteria: * ALT or AST ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal * Alkaline phosphatase ≤ 4 times ULN AND ALT and AST normal * ALT or AST \< 1.5 times ULN AND alkaline phosphatase \< 2.5 times ULN * Free of serious infection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No prior malignancy allowed for purposes of determining disease-free or overall survival except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease free for 5 years * No unstable angina, history of congestive heart failure, or acute myocardial infarction within the past 6 months * No current symptomatic, neurosensory or neuromotor toxicity ≥ grade 2 * No other significant medical or psychiatric condition incompatible with the protocol PRIOR CONCURRENT THERAPY: * No prior chemotherapy or radiotherapy for head and neck cancer

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Related Publications (1)

• Psyrri A, Rampias T, Vermorken JB. The current and future impact of human papillomavirus on treatment of squamous cell carcinoma of the head and neck. Ann Oncol. 2014 Nov;25(11):2101-2115. doi: 10.1093/annonc/mdu265. Epub 2014 Jul 23.

  PMID: 25057165 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

Cisplatin; Docetaxel; Fluorouracil; Gemcitabine; Leucovorin; Gene Expression Profiling; Chemotherapy, Adjuvant; Biopsy; Neoadjuvant Therapy; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Genetic Techniques; Investigative Techniques; Combined Modality Therapy; Therapeutics; Drug Therapy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• Stephen I. Shibata, MD

  City of Hope Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2007
• First Posted: October 16, 2007
• Study Start: June 7, 2000
• Primary Completion: February 14, 2017
• Study Completion: July 2, 2024
• Last Updated: February 19, 2025
• Results First Posted: April 7, 2023

Record last verified: 2025-02