Positron Emission Tomography Using Fluoromisonidazole F 18 and Fludeoxyglucose F 18 to Find Oxygen in Tumor Cells of Patients Undergoing Treatment for Newly Diagnosed Stage IB, Stage II, Stage III, or Stage IV Cervical Cancer - Full Text View

Sponsors and Collaborators:	University of Washington National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00559377

Purpose

RATIONALE: 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.

PURPOSE: 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.

Condition	Intervention	Phase
Cervical Cancer	Drug: chemotherapy Other: 18F-fluoromisonidazole Other: tissue oxygen measurement Procedure: conventional surgery Radiation: fludeoxyglucose F 18 Radiation: radiation therapy	Phase II

MedlinePlus related topics: Cancer Radiation Therapy

Drug Information available for: Fluorodeoxyglucose F18

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label
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

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Overall survival [ Designated as safety issue: No ]
Disease free survival [ Designated as safety issue: No ]
Response to radiotherapy as measured by standard RECIST criteria [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	December 2007
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Primary

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

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).
Test [^18F] FMISO tumor uptake as a predictor of response in a subgroup of patients receiving radiotherapy.
Test the relationship between [^18F] FMISO uptake in the primary tumor and the volume of the primary tumor estimated by CT scan.
Test the reproducibility of [^18F] FMISO uptake in tumors by imaging the same patients on sequential days in a test-retest protocol.
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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

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

PATIENT CHARACTERISTICS:

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.

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior surgery or radiotherapy for cervical cancer
Other concurrent investigational agents allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00559377

Locations

United States, Washington
University Cancer Center at University of Washington Medical Center	Recruiting
Seattle, Washington, United States, 98195-6043
Contact: Clinical Trials Office - University Cancer Center at Universit 206-616-8289

Sponsors and Collaborators

University of Washington

National Cancer Institute (NCI)

Investigators

Study Chair:

Joseph G. Rajendran, MD

University of Washington

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	University Cancer Center at University of Washington Medical Center ( Joseph G. Rajendran )
Study ID Numbers:	CDR0000574114, UW-6143
Study First Received:	November 15, 2007
Last Updated:	April 14, 2009
ClinicalTrials.gov Identifier:	NCT00559377 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

cervical adenocarcinoma
cervical squamous cell carcinoma
stage IB cervical cancer
stage IIB cervical cancer

stage IIA cervical cancer
stage IIB cervical cancer
stage IVA cervical cancer
stage IVB cervical cancer

Study placed in the following topic categories:

Radiation-Sensitizing Agents
Ro 07-0741
Epidermoid Carcinoma
Squamous Cell Carcinoma

Adenocarcinoma
Carcinoma, Squamous Cell
Carcinoma

Additional relevant MeSH terms:

Radiation-Sensitizing Agents
Ro 07-0741
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009