Search Clinical Trials
By Condition
By Location (USA)
By Location (Other)
By Sponsor
Resources
Privacy Policy
About Us
Disclaimer
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, trips or professional assistance with a real medical doctor. We aren't docs. Always confer with your doctor 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 website committed 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 cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the effectualness of new does drugs. The intention of the studies / projects is to figure out particular human healthcare questions. Clinical trials are a popular manner for doctors, government agencies, and private sector corporations to detect cures for all forms 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 for volunteers to undergo medical treatment options before they are available to the general public. Most times the subjects get treatment for free of charge, and occasionally they are paid for their time. Occasionally 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. Subjects frequently get the best healthcare possible for their EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma condition. Hazards are a reality, however, and could include more or frequent mD visits, health risks (possibly life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with exacting guidelines to protect clinical trials patients.

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 Cervical Cancer Studies:
1. Evaluation of the Addition of Herceptin to Standard Chemotherapy in the Neoadjuvant Setting for Operable Breast Cancer

2. Vaccine Therapy in Treating Patients With Advanced or Metastatic Cancer

3. A Study of ABT-751 in Patients With Recurrent Breast Cancer After Taxane (Taxol or Taxotere) Therapy.

4. Evaluation of Differing Taxanes/Taxane Combinations on the Outcomes of Patients with Operable Breast Cancer

5. Study of Inhaled Doxorubicin (Adriamycin) to Treat Advanced Lung Cancer

Related Studies:

Other Cervical 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

Modify your Search

  Other Cervical Cancer Clinical Trials
  Other Ontario Clinical Trials
  Other Toronto Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103