Cervical Adenocarcinoma Clinical Trial
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
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.
Status | Completed |
Enrollment | 16 |
Est. completion date | May 2014 |
Est. primary completion date | July 2012 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
United States | University of Washington Medical Center | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall Survival (OS) | Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the survival outcome variables. | For up to 2 years | No |
Primary | Disease-free Survival (DFS) | Evaluate the value of pre-treatment FMISO results (T:B and HV) for all patients to predict the disease free survival outcome variables. | Up to 2 years | No |
Secondary | Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor | The value of the biomarker by IHC analyses relates primarily to validating the information content of FMISO images. | Up to 2 years | No |
Secondary | Relationship Between Ki67 and Regional FMISO Uptake in Tumor | The value of the biomarker Ki67 analyses relates primarily to validating the information content of FMISO images. | Up to 2 years | No |
Secondary | Response to XRT Using RECIST | Response for the XRT is evaluated by the radiation oncologists as per standard clinical protocols | time to disease progression or 2 years following first FMISO scan | No |
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