Paclitaxel, Carboplatin and Radiotherapy as Induction Therapy in Locally Advanced Head and Neck Cancer

NCT00176254 | Completed Phase 2 Results

• 1 other identifier: 00-H&N-11-BMS
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study utilizes two cycles of Paclitaxel and Carboplatin chemotherapies followed by four small doses of radiation, prior to other treatment (surgery or radiation). This study is evaluating if radiation as a chemoenhancer increases the response rate of initial therapy.

Conditions

Squamous Cell Carcinoma

Keywords

head and neck; squamous cell carcinoma; squamous cell; carcinoma; paclitaxel; carboplatin; radiotherapy; induction therapy

Outcome Measures

Primary Outcomes (1)

• Response Rate to Induction Chemotherapy Prior to Definitive Therapy (Surgery or Radiation)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  assessed pre-study and once between days 36-57

Secondary Outcomes (4)

• Frequency of Severe (>/= Grade 3) Toxicities

  assessed starting on day 1 through study day 58 or until toxicity resolves

• 5 Year Overall Survival Rates

  5 years post study

• 5 Year Disease-specific Survival

  5 years

• 5 Year Progression Free Survival

  5 years

Study Arms (1)

Induction chemotherapy and radiation

EXPERIMENTAL

Induction chemotherapy with low dose radiation

Radiation: Radiotherapy; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Radiotherapy RADIATION

80 centigray (cGy) on Day 1 \& 2 and 22 \& 23 of chemotherapy

Induction chemotherapy and radiation

Paclitaxel DRUG

225 mg/m2 intravenously over three hours on Days 1 and 22

Also known as: Taxol

Induction chemotherapy and radiation

Carboplatin DRUG

Area under the curve (AUC) of 6 will be given intravenously over 30 minutes on days 1 and 22

Also known as: Paraplatin, CBDCA

Induction chemotherapy and radiation

Eligibility Criteria

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

You may qualify if:

• Adult patients greater than 18 years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
• Patients with pathologically documented bulky T2, III and IV squamous cell cancer of the head and neck (excluding M1 disease), within 2 months of diagnosis. Bulky T2 tumors are defined as those that have a volume of disease greater than 35 cm3 as measured by CT or MRI scan (26).
• Patients will be medically fit for undergoing chemotherapy. Specifically:
• no evidence of active angina pectoris or ventricular arrhythmias; no myocardial infarction within the last six months. (Patients with medically controlled hypertension or congestive heart failure are eligible.)
• an absolute neutrophil count of \> 1000/uL and platelet count \> 100,000/microliter (uL)
• serum total bilirubin \< 1.5 mg/dL
• Creatinine Clearance greater than 50 ml/min
• Using an actual or calculated creatinine clearance using the formula:
• (140 - age) x (wgt in kg)\*/(serum creatinine)x(72)\*= multiply by 0.85 for females
• if a pre-existing grade I neuropathy exists, patients must be willing to risk worsening neuropathy secondary to Paclitaxel. Patients with grade II or greater neuropathy will be excluded from study.
• ability to give written, informed consent to participate in the trial.
• Patients will have measurable disease as determined by MRI or CT scan or evaluable disease determined by panendoscopy to be eligible for enrollment on this study.

You may not qualify if:

• Pregnant females. Males and women of childbearing potential must use effective contraception in order to prevent pregnancy during therapy.
• Patients with a history of previous or current malignancy at other sites diagnosed within the last 5 years, with the exception of adequately treated carcinoma in-situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies, who remain free of recurrence or metastases for greater than five years are eligible.
• Patients with active infection will not be eligible for this protocol until the infection is treated and the symptoms have clinically resolved.
• Patients with a history of allergy to drugs utilizing Cremophor in the formulation.
• Prior induction chemotherapy, prior irradiation or surgery will not be allowed.
• Patients with metastatic disease will not be eligible for this study.
• Patients with grade II or greater peripheral neuropathy will be excluded from study.

Sponsors & Collaborators

• Susanne Arnold: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Carcinoma

Interventions

Radiotherapy; Paclitaxel; Carboplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Therapeutics; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Coordination Complexes

Limitations and Caveats

Heterogeneity of post-induction treatment given. While definitive therapy did differ, it was stratified by response to induction therapy, an accepted practice. Conclusions remain exploratory, because of the small sample size and heterogeneity.

Results Point of Contact

• Title: Dr. Emily Van Meter/Assistant Professor, Division of Cancer Biostatistics
• Organization: University of Kentucky

emily.vanmeter@uky.edu

859-323-3076

Study Officials

• Susanne Arnold, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: May 1, 2000
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: May 16, 2023
• Results First Posted: January 23, 2014

Record last verified: 2023-04