Cytochlor and Tetrahydrouridine as Radiosensitizers and Cisplatin Combined With Radiation Therapy in Treating Patients With Advanced Squamous Cell Carcinoma of the Oral Cavity (Mouth) or Oropharynx (Throat)

NCT00077051 | Completed Phase 1

• 3 other identifiers: 20020154SCCC-2002033NCI-6301
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Radiosensitizing drugs, such as cytochlor and tetrahydrouridine, may make tumor cells more sensitive to radiation therapy. Drugs used in chemotherapy, such as cisplatin work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combining radiosensitizers with chemotherapy and radiation therapy may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of cytochlor when given together with tetrahydrouridine, cisplatin and radiation therapy in treating patients with advanced squamous cell carcinoma of the oral cavity (mouth) or oropharynx (throat).

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx

Study Arms (1)

Single Arm

EXPERIMENTAL

Drug: cisplatin; Drug: cytochlor; Drug: tetrahydrouridine; Radiation: radiation therapy

Interventions

cisplatin DRUG

Single Arm

cytochlor DRUG

Single Arm

tetrahydrouridine DRUG

Single Arm

radiation therapy RADIATION

Single Arm

Eligibility Criteria

• Age: 21 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed squamous cell carcinoma of the oral cavity or oropharynx * Stage III disease not eligible for surgery * Stage IV disease allowed if patient is not eligible for chemotherapy or refused chemotherapy * No distant metastasis * Previously untreated disease * No osteoradionecrosis in patients with tumors involving the maxilla * Tumor tissue/normal adjacent tissue (T/N) ratio for dC kinase and dCMP deaminase greater than 2.5 PATIENT CHARACTERISTICS: Age * Over 21 Performance status * Karnofsky 80-100% OR * ECOG 0-1 Life expectancy * More than 6 months Hematopoietic * Absolute neutrophil count greater than 1,500/mm\^3 * WBC at least 3,000/mm\^3 * Platelet count greater than 100,000/mm\^3 Hepatic * AST/ALT less than 2.5 times upper limit of normal * Bilirubin normal Renal * Creatinine normal OR * Creatinine clearance greater than 60 mL/min Cardiovascular * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No impending carotid rupture Other * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study treatment * HIV negative * No other concurrent uncontrolled illness * No active or ongoing infection * No alcohol dependence * No psychiatric illness or social situation that would preclude study compliance * No other malignancy within the past 3 years except low-risk, non-melanomatous skin cancer, carcinoma in situ (e.g., breast, cervix, or bladder), or stage T1-2, low-to-moderate grade prostate cancer (Gleason score no greater than 7) PRIOR CONCURRENT THERAPY: Biologic therapy * No concurrent immunotherapy Chemotherapy * See Disease Characteristics * No other concurrent chemotherapy Endocrine therapy * No concurrent hormonal therapy except contraceptives or replacement steroids Radiotherapy * Not specified Surgery * See Disease Characteristics Other * No prior therapy for head and neck cancer * No other concurrent experimental medications * No other concurrent anticancer therapy * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

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

Interventions

Cisplatin; Tetrahydrouridine; Radiotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Therapeutics

Study Officials

• Luis E. Raez, MD, FACP

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

• May Abdel-Wahab, MD, PhD

  University of Miami Sylvester Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2004
• First Posted: February 11, 2004
• Study Start: April 1, 2004
• Primary Completion: July 1, 2007
• Study Completion: July 1, 2007
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

US (1)