Paclitaxel, Carboplatin And Low Dose Radiation As Induction Therapy In Locally Advanced Head And Neck Cancer

NCT00176267 | Completed Phase 2

• 1 other identifier: 02-H&N-15-BMS
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being performed utilizing two cycles of Paclitaxel and Carboplatin, plus low doses radiation as initial therapy prior to other treatment (surgery or radiation). The study is assessing if utilization of low doses radiation as a chemoenhancer will further increase the response rate seen with 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 (2)

• Response rate

  assessed at baseline and once between days 42 and 56, then repeated every 6 months until disease progression

• Pathologic complete responses

  assessed between 3 and 24 hours after the last dose of radiation

Secondary Outcomes (3)

• Toxicity

  assessed starting day 1 through study completion day 56 or until toxicities resolve

• Quality of Life

  assessed pre-study and once between study days 42 and 56

• Overall survival

  throughout study treatment duration and then every 3 months after study completion

Study Arms (1)

1

EXPERIMENTAL

Radiation: Radiotherapy; Drug: Paclitaxel; Drug: Carboplatin

Interventions

Radiotherapy RADIATION

50 cGy on days 1, 2, 8, 15, 22, 23, 29 \& 36 of chemotherapy

1

Paclitaxel DRUG

75 mg/m2 intravenously over one hour on Days 1, 8, 15, 22, 29 and 36

1

Carboplatin DRUG

AUC of 6 on Days 1 \& 22

1

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.
• ECOG performance status of 0, 1 or 2.
• Patients with pathologically documented bulky T2, III and IV SCCHN (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 (28).
• Patients will be medically fit for undergoing chemotherapy. Specifically:
• no evidence of active angina pectoris or ventricular arrhythmia's; 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/uL
• serum total bilirubin \< 1.5 mg/dL
• Creatinine Clearance greater than 60 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 or indirect laryngoscopy 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 chemotherapy, prior irradiation or surgery for SCCHN 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

Study Officials

• Susanne Arnold, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Director for Clinical Translation

Study Record Dates

• First Submitted: September 9, 2005
• First Posted: September 15, 2005
• Study Start: September 1, 2002
• Primary Completion: January 1, 2005
• Study Completion: January 31, 2017
• Last Updated: June 1, 2023

Record last verified: 2023-05