Oxaliplatin and Fluorouracil Plus Radiation Therapy in Treating Patients With Primary Esophageal or Stomach Cancer

NCT00004257 | Completed Phase 1

• 4 other identifiers: CDR0000067504ALB-RPCI-DS-99-08RPCI-DS-99-08NCI-T99-0061
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining more than one drug and combining chemotherapy with radiation therapy may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining oxaliplatin and fluorouracil plus radiation therapy in treating patients who have primary esophageal or stomach cancer.

Conditions

Esophageal Cancer

Keywords

stage I esophageal cancer; stage II esophageal cancer; stage III esophageal cancer; squamous cell carcinoma of the esophagus; adenocarcinoma of the esophagus

Interventions

fluorouracil DRUG

oxaliplatin DRUG

conventional surgery PROCEDURE

radiation therapy RADIATION

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed primary squamous cell carcinoma or adenocarcinoma of the thoracic esophagus (below 20 cm from incisors) or gastroesophageal (GE) junction * Stage I-III * Bronchoscopy with biopsy and cytology required if primary esophageal cancer is less than 26 cm from incisors * No disease outside esophagus and peri-esophageal soft tissue * GE junction tumors must be confined to no greater than 2 cm into the gastric cardia * Supraclavicular lymph nodes at station 1 must be less than 1.5 cm or nonpalpable by physical examination * Nodes 1.5 cm or greater or palpable by physical examination must be confirmed to be nonmalignant by biopsy * Subdiaphragmatic lymph nodes at stations 15-20 must be no greater than 1.5 cm * No recurrent disease * No known brain metastases PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * WBC at least 3,000/mm3 * Granulocyte count at least 1,500/mm3 * Platelet count at least 100,000/mm3 Hepatic: * Bilirubin normal * AST/ALT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN Renal: * Creatinine normal OR * Creatinine clearance at least 60 mL/min Cardiovascular: * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No grade 2 peripheral neuropathy * No history of allergy to platinum compounds * No history of allergy to antiemetics appropriate for administration in conjunction with protocol-directed chemotherapy * No other concurrent uncontrolled illness * No ongoing or active infection * No other malignancy within the past 5 years PRIOR CONCURRENT THERAPY: Biologic therapy: * No colony-stimulating factor therapy during first study course Chemotherapy: * No prior chemotherapy for esophageal cancer * At least 4 weeks since other prior chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiotherapy for esophageal cancer * At least 4 weeks since other prior radiotherapy Surgery: * No prior resection or attempted resection of esophageal cancer Other: * No other concurrent investigational drugs * No other concurrent commercial agents or therapies for esophageal cancer * No concurrent highly active antiretroviral agents (HAART) 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

• Albany Medical College: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263-0001, United States

Location

Related Publications (3)

• Smith PF, Booker B, Pendyala L, et al.: Pharmacokinetic modeling of oxaliplatin with and without 5-FU and radiation. [Abstract] Proc Am Assoc Cancer Res 42: A-2913, 542, 2001.

  BACKGROUND

• Khushalani N, Nava H, Leichman CG, et al.: A phase I study of oxaliplatin in combination with continous infusion 5-fluorouracil and radiation in esophagus cancer. [Abstract] Proc Am Assoc Cancer Res 42: A-3751, 697, 2001.

  RESULT

• Pendyala L, Leichman CG, Clark K, et al.: Oxaliplatin, 5-fluorouracil, and radiation in cancer of the esophagus: a pharmacokinetic (PK)/molecular correlates study. [Abstract] Proc Am Assoc Cancer Res 42: A-3347, 623, 2001.

  RESULT

MeSH Terms

Conditions

Esophageal Neoplasms; Esophageal Squamous Cell Carcinoma; Adenocarcinoma Of Esophagus

Interventions

Fluorouracil; Oxaliplatin; Radiotherapy

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Coordination Complexes; Organic Chemicals; Therapeutics

Study Officials

• Lawrence P. Leichman, MD

  Albany Medical College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 28, 2000
• First Posted: April 18, 2003
• Study Start: January 1, 2000
• Study Completion: January 1, 2004
• Last Updated: March 26, 2013

Record last verified: 2007-12

Locations

US (1)