Arsenic Trioxide in Treating Patients With Advanced Cancer of the Esophagus or Gastroesophageal Junction

NCT00061958 | Terminated Phase 2

• 4 other identifiers: NCI-2012-02534DM02-172N01CM17003CDR0000302483
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well arsenic trioxide works in treating patients with metastatic or unresectable cancer of the esophagus or gastroesophageal junction. Drugs used in chemotherapy such as arsenic trioxide use different ways to stop tumor cells from dividing so they stop growing or die

Conditions

Adenocarcinoma of the Esophagus; Stage III Esophageal Cancer; Stage IV Esophageal Cancer

Outcome Measures

Primary Outcomes (1)

• Objective response (OR) defined as a complete or partial remission, evaluated using RECIST criteria

  8 weeks

Secondary Outcomes (2)

• Duration of response

  From the time measurement criteria are met for CR or PR until the first date that recurrent or progressive disease is objectively documented, assessed up to 6 months

• Toxicity graded according to the Common Toxicity Criteria version 2

  Up to 6 months

Study Arms (1)

Treatment (arsenic trioxide)

EXPERIMENTAL

Patients receive a loading dose of arsenic trioxide IV over 2 hours on days 1-5 on week 1. Beginning on week 2, patients receive a maintenance dose of arsenic trioxide IV twice weekly thereafter. Courses repeat every 4 weeks for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients achieving a CR continue to receive therapy for at least 6 months beyond CR.

Drug: arsenic trioxide

Interventions

arsenic trioxide DRUG

Given IV

Also known as: Arsenic (III) Oxide, Arsenic Sesquioxide, Arsenous Acid Anhydride, AS2O3, Trisenox

Treatment (arsenic trioxide)

Eligibility Criteria

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

You may qualify if:

• Histologically confirmed adenocarcinoma of the esophagus or gastroesophageal junction
• Metastatic or unresectable local-regional disease
• Osseous metastasis as the only site of disease not eligible
• Measurable disease
• Mediastinal or hilar lymph nodes must be at least 2.0 cm in diameter by CT scan or MRI to be considered measurable
• No known brain metastases
• Performance status - Zubrod 0-2
• Performance status - Karnofsky 60-100%
• At least 12 weeks
• Absolute granulocyte count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 8 g/dL
• Bilirubin no greater than 1.5 mg/dL
• SGOT and/or SGPT no greater than 2.0 times upper limit of normal (ULN)
• Creatinine no greater than 1.5 times ULN

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Adenocarcinoma Of Esophagus; Esophageal Neoplasms

Interventions

Arsenic Trioxide

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Arsenicals; Inorganic Chemicals; Oxides; Oxygen Compounds

Study Officials

• Jaffer Ajani

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: June 1, 2003
• Primary Completion: April 1, 2005
• Last Updated: January 23, 2013

Record last verified: 2013-01

Locations

US (1)