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Completed

NCT Number: NCT00004246

Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effectiveness of radiation therapy plus fludarabine in treating patients who have locally advanced cancer of the mouth, pharynx, or larynx.

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Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Texas - MD Anderson Cancer Center

Houston, Texas, 77030-4009, United States

About this study

OBJECTIVES: I. Determine the maximum tolerated dose of fludarabine that can be given during the sixth and seventh weeks of radiotherapy in patients with locally advanced squamous cell carcinoma of the oral cavity, pharynx, or larynx, based on the systemic toxicity of the drug and the acute mucosal reactions in the irradiated fields. II. Document the qualitative and quantitative toxicity of this combination therapy in this patient population.

OUTLINE: This is a dose escalation study of fludarabine. Patients receive radiotherapy on days 1-5 for 7 weeks. Patients receive fludarabine IV on days 1-5 of weeks 6 and 7 of radiotherapy. Fludarabine is administered 3-4 hours prior to daily radiotherapy. Cohorts of 3 patients receive escalating doses of fludarabine until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose that produces a severe toxicity rate nearest to 20%. Patients are followed every 4 weeks after the completion of treatment until acute reactions have resolved, then every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years.

PROJECTED ACCRUAL: A maximum of 18 patients will be accrued for this study within 1.5 years.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS: Histologically confirmed squamous cell carcinoma of the oral cavity, pharynx, or larynx for which surgery would result in significant functional impairment Stage III or IV (T3-4 or N2-3) No distant metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Zubrod 0-2 Life expectancy: At least 6 months Hematopoietic: Granulocyte count at least 1,500/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT less than 4 times upper limit of normal PT/PTT normal Renal: Creatinine no greater than 1.5 mg/dL Other: Not pregnant or nursing Fertile patients must use effective contraception No other concurrent acute illness or infection

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy Surgery: See Disease Characteristics

Treatment and study plan

fludarabine phosphate

Drug

IV on days 1-5 of weeks 6 and 7 of radiotherapy, administered 3-4 hours prior to daily radiotherapy.

Other names: Fludara, Fludarabine

Radiation Therapy (RT)

Radiation

Days 1-5 for 7 weeks

Other names: radiotherapy

Primary outcomes

  1. Maximum Tolerated Dose (MTD) of Fludarabine During Sixth & Seventh Weeks of Radiotherapy

    Time frame: Every 4 weeks

    MTD based on systemic toxicity of drug and acute mucosal reactions in the irradiated fields.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck

Important dates

Study start
1995
Primary completion
2002
Study completion
2002
First posted
May 3, 2004
Registry last updated
Oct 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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