Clinical trial · Interventional

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

NCT00004261CI-TRIAL-00031765terminatedPhase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Lack of patient accrual

Summary

Brief summary (as posted)

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.

Conditions

Conditions (5)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92
Cervical Cancer	Malignant Cervical Neoplasm	CURATED_EXACT	0.92
Head and Neck Cancer	Malignant Head and Neck Neoplasm	ALIAS	0.90
Prostate Cancer	Malignant Prostate Neoplasm	CURATED_EXACT	0.92
Sarcoma	Sarcoma	ONTOLOGY_EXACT	0.98

Interventions

Interventions (5)

Intervention	Type	Mapped drug	Match
biopsy	Procedure	—	UNRESOLVED
EF5	Drug	—	UNRESOLVED
flow cytometry	Other	—	UNRESOLVED
fluorescent antibody technique	Other	—	UNRESOLVED
immunohistochemistry staining method	Other	—	UNRESOLVED

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Dec 1, 1999
Primary completion: Jun 1, 2002
Completion: —
First posted: Dec 11, 2003
Last update posted: Feb 22, 2018
Lead sponsor: University Health Network, Toronto OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: 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

Brief summary (as posted)

Conditions (5)

Interventions (5)

Eligibility (as posted)

Publications (0)

Locations by country (1)