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
18 Years
N/A
Both
Breast Cancer, Cervical Cancer, Head and Neck Cancer, Prostate Cancer, Sarcoma
Trial Information
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
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.
Inclusion 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
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Diagnostic
Principal Investigator
Anthony Fyles, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Princess Margaret Hospital, Canada
Authority:
United States: Federal Government
Study ID:
CDR0000067516
NCT ID:
NCT00004261
Start Date:
December 1999
Completion Date:
Related Keywords:
- Breast Cancer
- Cervical Cancer
- Head and Neck Cancer
- Prostate Cancer
- Sarcoma
- 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 IIB prostate cancer
- stage IIA 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
- stage 0 nasopharyngeal cancer
- stage 0 oropharyngeal cancer
- stage 0 laryngeal cancer
- stage 0 hypopharyngeal cancer
- stage I salivary gland cancer
- stage II salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- recurrent salivary gland cancer
- untreated metastatic squamous neck cancer with occult primary
- recurrent metastatic squamous neck cancer with occult primary
- stage 0 lip and oral cavity cancer
- stage IV adult soft tissue sarcoma
- stage I lip and oral cavity cancer
- stage II lip and oral cavity cancer
- stage III lip and oral cavity cancer
- stage IV lip and oral cavity cancer
- recurrent lip and oral cavity cancer
- stage I hypopharyngeal cancer
- stage II hypopharyngeal cancer
- stage III hypopharyngeal cancer
- stage IV hypopharyngeal cancer
- recurrent hypopharyngeal cancer
- stage I laryngeal cancer
- stage II laryngeal cancer
- stage III laryngeal cancer
- stage IV laryngeal cancer
- recurrent laryngeal cancer
- stage I paranasal sinus and nasal cavity cancer
- stage II paranasal sinus and nasal cavity cancer
- stage III paranasal sinus and nasal cavity cancer
- stage IV paranasal sinus and nasal cavity cancer
- recurrent paranasal sinus and nasal cavity cancer
- stage I oropharyngeal cancer
- stage II oropharyngeal cancer
- stage III oropharyngeal cancer
- stage IV oropharyngeal cancer
- recurrent oropharyngeal cancer
- stage II adult soft tissue sarcoma
- stage I adult soft tissue sarcoma
- Breast Neoplasms
- Uterine Cervical Neoplasms
- Head and Neck Neoplasms
- Prostatic Neoplasms
- Sarcoma
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