Copper Cu 64-ATSM and PET/CT Scan in Predicting Disease Progression in Patients With Newly-Diagnosed Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Undergoing Chemoradiotherapy Per NCCN Guidelines - Full Text View

Purpose

RATIONALE: Diagnostic procedures, such as copper Cu 64-ATSM PET/CT scans, may help doctors predict how patients will respond to treatment.

PURPOSE: This phase II trial is studying how well copper Cu 64-ATSM PET/CT scans work in predicting disease progression in patients undergoing standard of care treatment with cisplatin and radiation therapy (external beam and beachytherapy) per NCCN guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer.

Condition	Intervention	Phase
Cervical Cancer	Drug: parenteral chemotherapy Other: imaging biomarker analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Radiation: copper Cu 64-ATSM Radiation: fludeoxyglucose F 18 Radiation: radiation therapy	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Cancer Cervical Cancer Nuclear Scans

Drug Information available for: Fludeoxyglucose F 18

U.S. FDA Resources

Further study details as provided by American College of Radiology Imaging Network:

Primary Outcome Measures:

Relationship between copper Cu 64-ATSM uptake in the primary tumor and progression-free survival after chemoradiotherapy [ Time Frame: Three years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Relationship between copper Cu 64-ATSM uptake and overall survival [ Time Frame: Three years ] [ Designated as safety issue: No ]
Relationship between copper Cu 64-ATSM uptake and rates of local recurrence and development of distant metastasis [ Time Frame: Three years ] [ Designated as safety issue: No ]
Relationship between copper Cu 64-ATSM uptake and frequency of complete metabolic response [ Time Frame: Three years ] [ Designated as safety issue: No ]
Accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease [ Time Frame: Three years ] [ Designated as safety issue: No ]
Correlation between copper Cu 64-ATSM uptake and tumor volume at study entry and lymph node metastasis at diagnosis [ Time Frame: Two weeks ] [ Designated as safety issue: No ]
Relationship of copper Cu 64-ATSM uptake and markers of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN [ Time Frame: Three years ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2009
Estimated Primary Completion Date:	June 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Copper ATSM	Drug: parenteral chemotherapy Other: imaging biomarker analysis Other: immunohistochemistry staining method Other: laboratory biomarker analysis Radiation: copper Cu 64-ATSM Radiation: fludeoxyglucose F 18 Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

Primary

To define the role of pre-therapy ^64Cu-labeled diacetyl-bis(N4-methylthiosemicarbazone) (copper Cu 64-ATSM) in predicting prognosis and determining the behavior of an invasive squamous cell cervical cancer in patients with newly-diagnosed stage IB2-IVA cervical squamous cell carcinoma.
To determine whether higher copper Cu 64-ATSM uptake is associated with lower progression-free survival of these patients after chemoradiotherapy.

Secondary

To determine if higher copper Cu 64-ATSM uptake is associated with lower overall survival of these patients.
To determine if higher copper Cu 64-ATSM uptake is associated with earlier primary cervical tumor recurrence and a higher rate of development of distant metastatic disease in these patients.
To determine if higher copper Cu 64-ATSM uptake is associated with a lower frequency of complete metabolic response on FDG-PET/CT scan performed 3 months after completion of radiotherapy and chemotherapy.
To estimate the accuracy of copper Cu 64-ATSM uptake as a predictor of progression-free survival, overall survival, primary tumor recurrence, and future development of distant metastatic disease in these patients.
To evaluate the performance of copper Cu 64-ATSM uptake as a predictor of lymph node metastasis at study entry.
To evaluate whether copper Cu 64-ATSM uptake correlates with tumor volume at study entry.
To examine the relationship between tumor uptake of copper Cu 64-ATSM and other markers of tumor hypoxia, including VEGF, GLUT-1, CA-IX, and OPN.
To compare the predictive ability of pre-therapy copper Cu 64-ATSM-PET to that of post-therapy FDG-PET/CT scan.
To assess whether pre-therapy FDG-PET/CT findings are predictive of progression-free survival.

OUTLINE: This is a multicenter study.

Patients receive copper Cu 64-ATSM IV and undergo PET/CT scan over 30 minutes 30-40 minutes later. Within 4 weeks after copper Cu 64-ATSM-PET/CT scan, patients begin planned concurrent standard of care chemoradiotherapy comprising 6 weeks of radiotherapy (external beam and brachytherapy)and weekly cisplatin administration per NCCN guidelines. Patients then undergo FDG-PET/CT scan 3 months after completion of chemoradiotherapy.

Tissue samples from previously collected cervical biopsy (obtained for diagnosis) are used for detecting hypoxic markers by immunohistochemistry analysis.

After completion of study intervention, patients are followed for every 3 months for 2 years and then every 6 months for 1 year.

Eligibility

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

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed primary invasive cervical squamous cell carcinoma
- Newly diagnosed disease
- Stage IB2 - IVA disease based on FIGO staging system
Plan to receive standard of care treatment with concurrent cisplatin and radiation therapy (external beam and brachytherapy) per NCCN guidelines
- Must be scheduled to receive 6 weekly courses of cisplatin
Meets 1 of the following criteria:
- Pelvic nodal (or no nodal) disease only by FDG-PET/CT scan within 4 weeks of enrollment
- Para-aortic nodal metastasis by FDG-PET/CT scan within 4 weeks of enrollment, and patient will undergo radiotherapy to para-aortic nodes
- FDG-PET/CT scan at baseline if not meeting any of the above criteria
No stage IVB disease (distant metastases or supraclavicular metastasis) confirmed by FDG-PET/CT scan
No recurrent invasive carcinoma of the uterine cervix regardless of previous treatment
No know metastases to lungs, supraclavicular lymph nodes, or other organs outside of the pelvis or abdominal lymph nodes at time of diagnosis

PATIENT CHARACTERISTICS:

Karnofsky performance status 70-100%
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Able to lie flat for the duration of the PET/CT scan
No septicemia or severe infection
No uncontrolled or poorly controlled diabetes
No circumstances that would prevent completion of imaging studies or required clinical follow-up
No other prior or concurrent invasive malignancies, with the exception of non-melanoma skin cancer, within the past 5 years

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior pelvic or abdominal lymphadenectomy
No prior pelvic radiation therapy
No previous cancer treatment contraindicates this protocol therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794339

Contacts

Contact: Farrokh Dehdashti, MD

dehdashtif@mir.wustl.edu

Locations

United States, California
USC/Norris Comprehensive Cancer Center and Hospital	Recruiting
Los Angeles, California, United States, 90089-9181
Contact: Clinical Trials Office - USC/Norris Comprehensive Cancer Cente 323-865-0451
United States, Missouri
Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis	Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Farrokh Dehdashti, MD 314-747-1604 fryej@mir.wustl.edu

Sponsors and Collaborators

American College of Radiology Imaging Network

Investigators

Principal Investigator:	Farrokh Dehdashti, MD	Mallinckrodt Institute of Radiology at Washington University Medical Center
Study Chair:	David A. Mankoff, MD, PhD	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

For additional information on ACRIN 6682, visit ACRIN.ORG. This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:	NCT00794339 History of Changes
Other Study ID Numbers:	CDR0000624407, ACRIN-6682
Study First Received:	November 19, 2008
Last Updated:	February 4, 2013
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by American College of Radiology Imaging Network:

cervical squamous cell carcinoma
stage IIB cervical cancer
stage III cervical cancer
stage IV cervical cancer

stage IVA cervical cancer
stage IB cervical cancer
stage IIA cervical cancer

Additional relevant MeSH terms:

Uterine Cervical Neoplasms
Disease Progression
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases

Genital Diseases, Female
Disease Attributes
Pathologic Processes
Copper
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

Copper Cu 64-ATSM and PET/CT Scan in Predicting Disease Progression in Patients With Newly-Diagnosed Stage IB, Stage II, Stage III, or Stage IVA Cervical Cancer Who Are Undergoing Chemoradiotherapy Per NCCN Guidelines (ACRIN 6682)