Combination Chemotherapy and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer

NCT00352118 | Terminated Phase 2 Results

• 2 other identifiers: 2005LS012UMN-0502M67486
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel, cisplatin, and fluorouracil, 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. Giving combination chemotherapy together with radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving combination chemotherapy together with radiation therapy works in treating patients with locally advanced head and neck cancer. The doctor also wants to find out if patients who receive this treatment need a feeding tube 1 year after starting treatment.

Conditions

Head and Neck Cancer

Keywords

oral complications of radiation therapy; oral complications of chemotherapy; mucositis; xerostomia; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Feeding Tube Dependency

  All patients were non-evaluable and study was terminated early. There is no measure of outcome.

  at 12 months

Secondary Outcomes (6)

• Number of Days With Progression-free Survival

  Between date of registration to date of first treatment failure or death.

• Number of Days - Overall Survival

  Between date of registration to date of death.

• Number of Days With Disease Free Survival

  From Date of Registration to Date of First Treatment Failure or Death

• Time to Treatment Failure

  Number of Days from Complete or Partial Response to First Date of Recurrence or Progression

• Swallowing Ability - Quality of Life Scores

  Baseline, before chemoradiation, 30 days after last radiation treatment, every 3 months for the first year, then every 6 months for year 2.

Study Arms (1)

Chemotherapy + Low Dose Radiation

EXPERIMENTAL

Patients receiving chemotherapy and Low Dose (60 Gy) Radiation per protocol.

Biological: filgrastim; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Drug: fluorouracil; Procedure: conventional surgery; Radiation: radiation therapy

Interventions

filgrastim BIOLOGICAL

subcutaneously on Days 5-14, repeating every 3 weeks for 2 courses.

Also known as: G-CSF, Neupogen

Chemotherapy + Low Dose Radiation

pegfilgrastim BIOLOGICAL

If applicable on day 5, repeating every 3 weeks for 2 courses.

Also known as: Neulasta, G-CSF

Chemotherapy + Low Dose Radiation

cisplatin DRUG

Intravenous over 1 hour on day 1, every 3 weeks for 3 courses.

Also known as: CDDP, cisplatinum, cis-diamminedichloridoplatinum, Platinol AQ

Chemotherapy + Low Dose Radiation

docetaxel DRUG

Intravenous over 1 hour on day 1.

Also known as: Taxotere(R)

Chemotherapy + Low Dose Radiation

fluorouracil DRUG

Intravenous continuously on days 1-4.

Also known as: 5-FU, 5-fluorouracil, Adrucil

Chemotherapy + Low Dose Radiation

conventional surgery PROCEDURE

As appropriate, neck dissection.

Also known as: surgery

Chemotherapy + Low Dose Radiation

radiation therapy RADIATION

60 Gy 5 days/week x 6 weeks with cisplatin

Also known as: radiation

Chemotherapy + Low Dose Radiation

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed squamous cell carcinoma of the head and neck
• Stage IVA or IVB disease
• Stage III disease allowed provided patient may benefit from organ preservation or patient refused surgery
• Measurable or evaluable disease
• ECOG performance status 0-2
• Absolute neutrophil count ≥ 1,500/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Creatinine ≤ 1.5 mg/dL OR glomerular filtration rate ≥ 60 mL/min
• Bilirubin normal
• Alkaline phosphatase (AP) and AST or ALT must be within the following ranges:
• AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• AP ≤ 5 times ULN AND AST or ALT normal

You may not qualify if:

• Salivary gland, sinus, or nasopharyngeal primary disease
• Evidence of distant metastatic disease
• Pregnant or nursing
• Positive pregnancy test (Fertile patients must use effective contraception during study treatment and for 3 months after completion of study treatment)
• Other malignancy within the past 5 years except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other malignancy in which stage and nature of disease is such that it is unlikely to affect survival for the next 3 years
• Peripheral neuropathy ≥ grade 2
• Hearing loss ≥ grade 2
• Severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 and/or cisplatin or other platinum analogs
• Poor nutritional status, in the opinion of the investigator
• Active infection
• Active ischemic heart disease
• Myocardial infarction within the past 6 months
• Prior radiotherapy above the clavicles
• Prior chemotherapy
• Prior surgery to the primary tumor except biopsy

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

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

Interventions

Filgrastim; Granulocyte Colony-Stimulating Factor; pegfilgrastim; Cisplatin; Docetaxel; Fluorouracil; Surgical Procedures, Operative; Radiotherapy; Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; 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; Therapeutics; Physical Phenomena

Limitations and Caveats

All 4 patients received high dose radiation (66-70 Gy). The radiation oncologist on this study deemed low dose radiation treatment was not appropriate for these patients. Therefore, the study participants are not evaluable.

Results Point of Contact

• Title: Frank Ondrey, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

ondre002@umn.edu

612-625-3200

Study Officials

• Frank G. Ondrey, MD, PhD

  Masonic Cancer Center, University of Minnesota

  PRINCIPAL INVESTIGATOR

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: July 13, 2006
• First Posted: July 14, 2006
• Study Start: March 1, 2006
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: December 28, 2017
• Results First Posted: July 21, 2009

Record last verified: 2017-12

Locations

US (1)