Radiation Therapy Plus Fludarabine in Treating Patients With Locally Advanced Cancer of the Mouth, Pharynx, or Larynx
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|ClinicalTrials.gov Identifier: NCT00004246|
Recruitment Status : Completed
First Posted : May 3, 2004
Last Update Posted : October 25, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: Fludarabine Phosphate Radiation: Radiation Therapy (RT)||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Fludarabine With Radiotherapy in Patients With Locally Advanced Squamous Cell Carcinoma of the Head and Neck|
|Actual Study Start Date :||June 7, 1995|
|Actual Primary Completion Date :||December 2, 2002|
|Actual Study Completion Date :||December 2, 2002|
Experimental: RT + Fludarabine
Radiotherapy (RT) on Days 1-5 for 7 weeks + Fludarabine IV, 3-4 hours prior to daily RT, Days 1-5 of weeks 6 and 7 of RT
Drug: Fludarabine Phosphate
IV on days 1-5 of weeks 6 and 7 of radiotherapy, administered 3-4 hours prior to daily radiotherapy.
Radiation: Radiation Therapy (RT)
Days 1-5 for 7 weeks
Other Name: radiotherapy
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004246
|United States, Texas|
|University of Texas - MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4009|
|Study Chair:||K. Kian Ang, MD, PhD||M.D. Anderson Cancer Center|