Phase 2
Completed N=16
FDG and FMISO PET Hypoxia Evaluation in Cervical Cancer
Source: ClinicalTrials.gov NCT00559377 ↗Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Overall Survival (OS) — 11 participants still alive after 2 years — p=.42
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Survival (OS) |
11 | .42 |
| PRIMARY Disease-free Survival (DFS) |
10 | .58 |
| SECONDARY Relationship Between Hypoxia-related IHC Biomarkers and Regional FMISO Uptake in Tumor |
5; 5; 7; 7 | <0.05 sig |
| SECONDARY Relationship Between Ki67 and Regional FMISO Uptake in Tumor |
74 | — |
| SECONDARY Response to XRT Using RECIST |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00559377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.