Overview

This trial is active, not recruiting.

Conditions cervical adenocarcinoma, cervical squamous cell carcinoma, stage ib cervical cancer, stage iia cervical cancer, stage iib cervical cancer, stage iii cervical cancer, stage iva cervical cancer, stage ivb cervical cancer
Treatments 18f-fluoromisonidazole, fludeoxyglucose f 18, positron emission tomography, tissue oxygen measurement
Phase phase 2
Sponsor National Cancer Institute (NCI)
Start date November 2007
End date May 2011
Trial size 16 participants
Trial identifier NCT00559377, 7958, CDR0000574114, N01CM37008, NCI-2009-00257, UW IRB# 6143, UW-6143

Summary

This phase II trial is studying how well PET scans using fluoromisonidazole F 18 and fludeoxyglucose F 18 work in finding oxygen in tumor cells of patients undergoing treatment for newly diagnosed stage 1B, stage II, stage II, or stage IV cervical cancer. Diagnostic procedures using positron emission tomography (PET scan), fluoromisonidazole F 18, and fludeoxyglucose F 18 to find oxygen in tumor cells may help doctors predict how patients will respond to treatment.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose diagnostic
Arm
(Experimental)
Patients receive ^18F FMISO IV over 1 minute followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline. A subset of 10 patients undergo two ^18F FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of this imaging measurement.
18f-fluoromisonidazole 18F-FMISO
Undergo ^18F FMISO PET scan
fludeoxyglucose f 18 18FDG
Undergo ^18F FDG PET scan
positron emission tomography FDG-PET
Undergo ^18F-FMISO and ^18F FDG PET scan
tissue oxygen measurement
Undergo ^18 F FMISO PET and ^18F FDG PET

Primary Outcomes

Measure
Overall survival (OS)
time frame: For up to 2 years
Disease-free survival (DFS)
time frame: Up to 2 years
Response to radiotherapy as measured by standard Response Evaluation Criteria in Solid Tumors (RECIST) criteria
time frame: Assessed up to 2 years

Secondary Outcomes

Measure
Relationship between hypoxia-related biomarkers (HIF1-α and VEGF by immunohistochemistry [IHC]), proliferation biomarkers (microvascular density, p53, and Ki-67 by IHC), and regional fluoromisonidazole F 18 uptake in tumor
time frame: Up to 2 years

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: - Histologically confirmed squamous cell or adenocarcinoma of the uterine cervix - Clinical stage IB-IVB by FIGO criteria - Size of the primary tumor ≥ 2 cm as assessed by CT scan - Measurable disease - Scheduled to undergo radiotherapy, chemotherapy, or combined multimodality management - No prior cervical cancer diagnosis - No known brain metastases - ECOG performance status (PS) 0-2 (Karnofsky PS 60-100%) - Life expectancy > 12 months - Not pregnant - No nursing for 24 hours after fluoromisonidazole F 18 ([^18F] FMISO) PET scanning - Negative pregnancy test - Weight ≤ 400 lbs - Sufficiently healthy to undergo cancer treatment - Willing to undergo PET scanning with urinary bladder catheterization - Leukocytes ≥ 3,000/mm³ - Absolute neutrophil count ≥ 1,500/mm³ - Platelet count ≥ 100,000/mm³ - Total bilirubin normal - AST/ALT ≤ 2.5 times normal - Creatinine normal OR creatinine clearance ≥ 60 mL/min - No serious medical co-morbidities that would preclude definitive local therapy - No history of allergic reactions attributed to compounds of similar chemical or biologic composition to [^18F] FMISO - No concurrent uncontrolled illness including, but not limited to, any of the following: - Ongoing or active infection - Symptomatic congestive heart failure - Unstable angina pectoris - Cardiac arrhythmia - Psychiatric illness/social situations that would limit compliance with study requirements. - No prior surgery or radiotherapy for cervical cancer - Other concurrent investigational agents allowed

Additional Information

Official title A Phase 2 Study of Positron Emission Tomography Imaging With [18F]-Fluoromisonidazole (FMISO) and [18F]-Fluorodeoxyglucose (FDG) for Assessment of Tumor Hypoxia in Cervical Cancer
Principal investigator Joseph Rajendran
Description PRIMARY OBJECTIVES: I. Test the extent to which fluoromisonidazole F 18 ([^18F] FMISO) uptake predicts survival of patients undergoing therapy for newly diagnosed stage IB-IVB cervical cancer. SECONDARY OBJECTIVES: I. Test [^18F] FMISO tumor uptake as an independent predictor of response to therapy and that it provides additional predictive power over fludeoxyglucose F 18 ([^18F] FDG). II. Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy. III. Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume of the primary tumor estimated by CT scan. IV. Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol. V. Compare [^18F] FMISO PET or PET/CT scan with [^18F] FDG PET or PET/CT scan to test whether [^18F] FMISO is an independent predictor of treatment outcome. OUTLINE: Patients receive fluoromisonidazole F 18 ([^18F] FMISO) IV over 1 minute followed by PET scanning. Patients undergo a second [^18F] FMISO PET scan 4-8 weeks later. Patients who have not had a prior fludeoxyglucose F 18 ([^18F] FDG) PET scan as part of their routine clinical management undergo [^18F] FDG PET scanning at baseline. A subset of 10 patients undergo two [^18F] FMISO PET scans within a 48-hour period to evaluate the variability (test-retest) of this imaging measurement. Patients response to therapy is followed periodically until time to disease progression or for 2 years.
Trial information was received from ClinicalTrials.gov and was last updated in June 2014.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).