NCT00004261|TerminatedPhase 1
Study Stopped
Lack of patient accrual
EF5 Prior to Surgery or Biopsy in Patients With Breast, Prostate, or Cervical Cancer or High Grade Soft Tissue Sarcoma
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
3 other identifiers
CAN-OCI-T98-0048CDR0000067516NCI-T98-0048
Study Type
interventional
Target
N/A
Locations
1 country
Sites
1
Timeline
RegisteredDec 2003
StartedDec 1999
Brief Summary
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.
Trial Health
35
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Geographic Reach
1 country
1 active site
Status
terminated
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 1999
Completed2 months until next milestone
First Submitted
Initial submission to the registry
January 28, 2000
Completed2.3 years until next milestone
Primary Completion
Last participant's last visit for primary outcome
June 1, 2002
Completed1.5 years until next milestone
First Posted
Study publicly available on registry
December 11, 2003
CompletedLast Updated
February 22, 2018
Status Verified
February 1, 2018
Enrollment Period
2.5 years
First QC Date
January 28, 2000
Last Update Submit
February 20, 2018
Conditions
Keywords
stage I breast cancerstage II breast cancerstage IV breast cancerstage IIIA breast cancerbreast cancer in siturecurrent breast cancerstage IIIB breast cancerstage 0 cervical cancerstage III cervical cancerrecurrent cervical cancerstage IB cervical cancerstage IIB cervical cancerstage IVB cervical cancerstage IA cervical cancerstage IIA cervical cancerstage IVA cervical cancerinflammatory breast cancerstage III adult soft tissue sarcomarecurrent adult soft tissue sarcomastage I prostate cancerstage IIB prostate cancerstage IIA prostate cancerstage III prostate cancerstage IV prostate cancerrecurrent prostate cancerstage I nasopharyngeal cancerstage II nasopharyngeal cancerstage III nasopharyngeal cancerstage IV nasopharyngeal cancerrecurrent nasopharyngeal cancerstage 0 paranasal sinus and nasal cavity cancerstage 0 nasopharyngeal cancerstage 0 oropharyngeal cancerstage 0 laryngeal cancerstage 0 hypopharyngeal cancerstage I salivary gland cancerstage II salivary gland cancerstage III salivary gland cancerstage IV salivary gland cancerrecurrent salivary gland canceruntreated metastatic squamous neck cancer with occult primaryrecurrent metastatic squamous neck cancer with occult primarystage 0 lip and oral cavity cancerstage IV adult soft tissue sarcomastage I lip and oral cavity cancerstage II lip and oral cavity cancerstage III lip and oral cavity cancerstage IV lip and oral cavity cancerrecurrent lip and oral cavity cancerstage I hypopharyngeal cancerstage II hypopharyngeal cancerstage III hypopharyngeal cancerstage IV hypopharyngeal cancerrecurrent hypopharyngeal cancerstage I laryngeal cancerstage II laryngeal cancerstage III laryngeal cancerstage IV laryngeal cancerrecurrent laryngeal cancerstage I paranasal sinus and nasal cavity cancerstage II paranasal sinus and nasal cavity cancerstage III paranasal sinus and nasal cavity cancerstage IV paranasal sinus and nasal cavity cancerrecurrent paranasal sinus and nasal cavity cancerstage I oropharyngeal cancerstage II oropharyngeal cancerstage III oropharyngeal cancerstage IV oropharyngeal cancerrecurrent oropharyngeal cancerstage II adult soft tissue sarcomastage I adult soft tissue sarcoma
Interventions
Eligibility Criteria
Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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
Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.
Sponsors & Collaborators
Study Sites (1)
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9, Canada
MeSH Terms
Conditions
Breast NeoplasmsUterine Cervical NeoplasmsHead and Neck NeoplasmsProstatic NeoplasmsSarcomaBreast Carcinoma In SituUterine Cervical DysplasiaInflammatory Breast NeoplasmsNasopharyngeal NeoplasmsOropharyngeal NeoplasmsLaryngeal NeoplasmsHypopharyngeal NeoplasmsSalivary Gland NeoplasmsMouth Neoplasms
Interventions
Flow CytometryFluorescent Antibody TechniqueImmunohistochemistryBiopsy
Condition Hierarchy (Ancestors)
Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesUterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGenital Neoplasms, MaleGenital Diseases, MaleProstatic DiseasesMale Urogenital DiseasesNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeCarcinoma in SituCarcinomaNeoplasms, Glandular and EpithelialPrecancerous ConditionsPharyngeal NeoplasmsOtorhinolaryngologic NeoplasmsNasopharyngeal DiseasesPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesLaryngeal DiseasesRespiratory Tract DiseasesRespiratory Tract NeoplasmsMouth DiseasesSalivary Gland Diseases
Intervention Hierarchy (Ancestors)
Cell SeparationCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisCytophotometryFluorometryLuminescent MeasurementsPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesHistocytochemistryHistological TechniquesImmunologic TechniquesCytodiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, Operative
Study Officials
- STUDY CHAIR
Anthony Fyles, MD
Princess Margaret Hospital, Canada
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Purpose
- DIAGNOSTIC
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2000
First Posted
December 11, 2003
Study Start
December 1, 1999
Primary Completion
June 1, 2002
Last Updated
February 22, 2018
Record last verified: 2018-02