Clinical trial NCT00559377: FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
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
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2007-11-16
Enrollment: 16
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: For up to 2 years
measure: Disease-free Survival (DFS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor
timeFrame: Up to 2 years
measure: Relationship Between Ki67 and Regional FMISO Uptake in Tumor
timeFrame: Up to 2 years
measure: Response to XRT Using RECIST
timeFrame: time to disease progression or 2 years following first FMISO scan
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington Medical Center
state: Washington
Study officials:
affiliation: University of Washington
name: Joseph Rajendran
role: PRINCIPAL_INVESTIGATOR
References: