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EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma Clinical research trials and EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma clinical trial. Human subjects often get the best healthcare available for their EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma  EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
For Condition: Oropharyngeal Cancer,lip and oral cavity cancer,adult soft tissue sarcoma,Head and Neck Cancer,Breast Cancer,Salivary Gland Cancer,Prostate Cancer,Cervical Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Ontario Cancer Institute
Synopsis: RATIONALE: EF5 may detect the presence of oxygen in tumor cells and help plan effective cancer treatment. PURPOSE: Phase I trial to study the effectiveness of EF5 in detecting the presence of oxygen in tumor cells of patients who are undergoing surgery or biopsy for breast, prostate, or cervical cancer or high grade soft tissue sarcoma.
Details: OBJECTIVES: I. Determine the optimal dose of etanidazole derivative EF5 that is safely tolerated and provides optimal binding in resected tumor specimens or tumor biopsies in patients with breast, head and neck, prostate, or cervical carcinoma or high grade soft tissue sarcomas. II. Define the toxic effects of EF5 in this patient population. PROTOCOL OUTLINE: This is a dose-escalation study. Patients receive etanidazole derivative EF5 IV over 1-2 hours. Approximately 24-48 hours after EF5 treatment, patients undergo surgical resection or biopsy of tumor. Cohorts of 6 patients receive escalating doses of EF5 until the maximum tolerated dose (MTD) or optimal dose is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity. The optimal dose is defined as the dose level at or preceding the MTD and resulting in optimal tumor-to-normal-tissue binding. Patients are followed at 28 days. PROJECTED ACCRUAL: A total of 18-36 patients will be accrued for this study within 12-18 months.
Eligibility:
Study Type: Interventional, Diagnostic
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven breast, head and neck, prostate, or cervical carcinoma or high grade (defined as grades 2 or 3) soft tissue sarcoma; Sarcoma tumors must be confined to truncal or extremity locations - Must have a clinical condition and physiologic status which demonstrates that the appropriate or standard initial therapy for the tumor is surgical biopsy or resection - Tumors no greater than 15 cm in any diameter - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: Not specified - Endocrine therapy: Not specified - Radiotherapy: Not specified - Surgery: See Disease Characteristics --Patient Characteristics-- - Age: 18 and over - Menopausal status: Not specified - Performance status: ECOG 0 or 1 - Life expectancy: Not specified - Hematopoietic: Absolute neutrophil count greater than 2,000/mm3; Platelet count greater than 100,000/mm3 - Hepatic: Bilirubin less than 2.0 mg/dL - Renal: Creatinine less than 2.0 mg/dL OR Creatinine clearance greater than 50 mL/min - Cardiovascular: No significant cardiac disease that would preclude the safe use of general anesthesia - Pulmonary: No significant pulmonary disease that would preclude the safe use of general anesthesia - Other: Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception during and for 1 month after study; No grade 3 or 4 peripheral neuropathy
Total Enrollment:
Location and Contact Information:
Overall Study Official:
AnthonyFyles, Study Chair, Ontario Cancer Institute
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
Canada
Additional Information:
Study ID Numbers: CDR0000067516; CAN-OCI-T98-0048,NCI-T98-0048
Study Start Date: December 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004261
Other Salivary Gland Cancer Studies:
1. Gene Therapy in Treating Patients With Cancer
2. Cisplatin Plus Gemcitabine in Treating Patients With Advanced Squamous Cell Head and Neck Cancer
3. EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
4. Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer
5. Biological Therapy in Treating Patients With Metastatic Cancer
Related Studies:
Other Salivary Gland Cancer Clinical Trials
Other Ontario Clinical Trials
Other Toronto Clinical Trials
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
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