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| Sponsors and Collaborators: |
Princess Margaret Hospital, Canada National Cancer Institute (NCI) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00004261 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer Cervical Cancer Head and Neck Cancer Prostate Cancer Sarcoma |
Drug: EF5 Other: flow cytometry Other: fluorescent antibody technique Other: immunohistochemistry staining method Procedure: biopsy |
Phase I |
| Study Type: | Interventional |
| Study Design: | Diagnostic |
| Official Title: | A Phase I Trial of the Hypoxia Detection Agent EF5 (NSC 684681) in Patients With Cervix and Breast and Prostate Carcinomas, and High Grade Soft Tissue Sarcomas |
| Study Start Date: | December 1999 |
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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
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
PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Not specified Surgery: See Disease Characteristics
Contacts and Locations| Canada, Ontario | |
| Princess Margaret Hospital | |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Study Chair: | Anthony Fyles, MD | Princess Margaret Hospital, Canada |
More Information
| Study ID Numbers: | CDR0000067516, CAN-OCI-T98-0048, NCI-T98-0048 |
| Study First Received: | January 28, 2000 |
| Last Updated: | February 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00004261 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage I breast cancer stage II breast cancer stage IV breast cancer stage IIIA breast cancer breast cancer in situ recurrent breast cancer stage IIIB breast cancer stage 0 cervical cancer stage III cervical cancer recurrent cervical cancer stage IB cervical cancer stage IIB cervical cancer stage IVB cervical cancer stage IA cervical cancer stage IIA cervical cancer |
stage IVA cervical cancer inflammatory breast cancer stage III adult soft tissue sarcoma recurrent adult soft tissue sarcoma stage I prostate cancer stage II prostate cancer stage III prostate cancer stage IV prostate cancer recurrent prostate cancer stage I nasopharyngeal cancer stage II nasopharyngeal cancer stage III nasopharyngeal cancer stage IV nasopharyngeal cancer recurrent nasopharyngeal cancer stage 0 paranasal sinus and nasal cavity cancer |
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Genital Neoplasms, Male Prostatic Diseases Laryngeal Carcinoma Urogenital Neoplasms Hypopharyngeal Cancer Lip and Oral Cavity Cancer Neoplasms, Connective and Soft Tissue Soft Tissue Sarcomas Inflammatory Breast Cancer Salivary Gland Diseases Breast Diseases Immunoglobulins Nasopharyngeal Carcinoma |
Skin Diseases Breast Neoplasms Laryngeal Neoplasms Genital Diseases, Male Recurrence Carcinoma Oral Cancer Malignant Mesenchymal Tumor Antibodies Metastatic Squamous Neck Cancer With Occult Primary Head and Neck Neoplasms Sarcoma Prostatic Neoplasms |
|
Neoplasms by Histologic Type Skin Diseases Genital Neoplasms, Male Prostatic Diseases Breast Neoplasms Urogenital Neoplasms Genital Diseases, Male |
Neoplasms, Connective and Soft Tissue Neoplasms Neoplasms by Site Head and Neck Neoplasms Sarcoma Prostatic Neoplasms Breast Diseases |
