EF5 to Evaluate Tumor Hypoxia in Patients With High-Grade Soft Tissue Sarcoma or Mouth Cancer

Stopped early · Not applicable

Conditions studied: Stage I Adult Soft Tissue Sarcoma, Stage I Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage II Adult Soft Tissue Sarcoma, Stage II Squamous Cell Carcinoma of the Lip and Oral Cavity, Stage III Adult Soft Tissue Sarcoma, Stage III Squamous Cell Carcinoma of the Lip and Oral Cavity

In brief

This laboratory study is using EF5 to evaluate tumor hypoxia in patients with high-grade soft tissue sarcoma or mouth cancer. Using the drug EF5 to measure the oxygen level in tumor cells may help in planning cancer treatment

Key facts

Study ID

NCT00896961

Run by

National Cancer Institute (NCI)

People needed

120

Starts

2001-08-01

Last updated by the study team

2013-01-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically confirmed high-grade soft tissue sarcoma (STS) of the trunk or extremity or squamous cell carcinoma of the oral cavity for which surgical biopsy or resection is standard initial therapy
• Clinical imaging of mass that is likely to be STS or squamous cell carcinoma of the head and neck allowed if surgery is indicated prior to definitive diagnosis
• Planned resection and standard oncologic treatment
• No known distant metastatic disease
• ECOG 0-2
• WBC at least 2,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Bilirubin less than 2.0 mg/dL
• Creatinine less than 2.0 mg/dL OR creatinine clearance at least 50 mL/min
• No significant cardiac condition that would preclude study compliance
• Weight no greater than 130 kg
• No grade III or IV peripheral neuropathy
• No other medical condition that would preclude study compliance
• Not pregnant or nursing
• Fertile patients must use effective contraception
• See Disease Characteristics
• No chemotherapy within 3 months before planned surgery
• Preoperative radiotherapy allowed for STS
• No radiotherapy within 3 months before planned surgery
• No other concurrent investigational agents

Where it is running

• Abramson Cancer Center of The University of Pennsylvania — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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