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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by American College of Radiology Imaging Network
Sponsor:
Information provided by (Responsible Party):
American College of Radiology Imaging Network
ClinicalTrials.gov Identifier:
NCT00794339
First received: November 19, 2008
Last updated: August 19, 2013
Last verified: August 2013
  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 brachytherapy) 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:


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: December 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: August 19, 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
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Copper
Fluorodeoxyglucose F18
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Radiopharmaceuticals
Diagnostic Uses of Chemicals
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014