Phase II Trial of 64Cu-ATSM PET/CT in Cervical Cancer

NCT00794339 | Terminated Phase 2 Results DMC

• 4 other identifiers: CDR0000624407ACRIN-6682U01CA080098U01CA079778
• Study Type: interventional
• Target: 73
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Diagnostic procedures, such as 64Cu-labeled diacetyl-bis\[N4-methylthiosemicarbazone\] (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 National Comprehensive Cancer Network (NCCN) guidelines for newly-diagnosed stage IB, stage II, stage III, or stage IVA cervical cancer via the Federation of Gynecology and Obstetrics (FIGO) staging systems.

Conditions

Cervical Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Relationship Between Copper Cu 64-ATSM Uptake in the Primary Tumor and Progression-free Survival 3 Years After Chemoradiotherapy

  Progression-free survival (PFS) evaluated every 3 months for first 2 years and every 6 months during year 3 to determine PFS at 3years. Cu64-ATSM Uptake measured within 14 days of baseline Uptake is a measure of activity within a tumor 1. the maximum standardized uptake value (SUVmax = tracer uptake in ROI / (injected activity / patient weight)) 2. Tumor-to-Muscle uptake ratio (T/M, An FDG-PET/CT-guided circular region of interest of 1.0-1.5 cm in diameter is drawn around the most intense region of the primary tumor to calculate the maximum uptake within the region. In addition, regions of interest are drawn on bilateral gluteal muscle groups on at least 3 slices, and the mean uptake is calculated. The T/M is the ratio of these measurements.)

  every 3 months for first 2 years and every 6 months during year 3, up to 3 years

Secondary Outcomes (14)

• Copper Cu 64-ATSM T/M Uptake and Overall Survival

  every 3 months for first 2 years and every 6 months during year 3, up to 3 years

• Relationship Between Copper Cu 64-ATSM Uptake and Complete Metabolic Response

  3 months after completion of chemoradiation

• Primary Tumor Recurrence

  every 3 months for first 2 years and every 6 months during year 3, up to 3 years

• Lymph Node Metastasis at Baseline

  Two weeks

• Relationship of Copper Cu 64-ATSM Uptake T/M Ratio and Carbonic Anhydrase IX (CA-IX) Percentage of Tumor Cells Staining Score as a Marker of Tumor Hypoxia

  baseline

Study Arms (1)

Copper ATSM

EXPERIMENTAL

pre-therapy pelvic 64Cu-ATSM-PET/CT with Pre- and post- therapy FDG PET/CT

Drug: 64Cu-ATSM; Drug: FDG

Interventions

64Cu-ATSM DRUG

Also known as: copper 64, 64Cu Diacetyl-bis(N4-methylthiosemicarbazone)

Copper ATSM

FDG DRUG

Also known as: fludeoxyglucose F 18, Fluorodeoxyglucose (18F), 18F-FDG, 18F-fluorodeoxyglucose

Copper ATSM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• American College of Radiology: lead
• National Cancer Institute (NCI): collaborator
• American College of Radiology Imaging Network: collaborator

Study Sites (2)

USC/Norris Comprehensive Cancer Center and Hospital

Los Angeles, California, 90089-9181, United States

Location

Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis

St Louis, Missouri, 63110, United States

Location

Related Links

• National Cancer Institute's Clinical trial database

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

copper(64)TETA-phenyalanyl-tyrosyl(3)-octreotate; Fluorodeoxyglucose F18

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates

Results Point of Contact

• Title: Donna Hartfeil
• Organization: ACR

dhartfeil@acr.org

215-717-2765

Study Officials

• Farrokh Dehdashti, MD

  Mallinckrodt Institute of Radiology at Washington University Medical Center

  PRINCIPAL INVESTIGATOR

• David A. Mankoff, MD, PhD

  University of Washington

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: July 29, 2009
• Primary Completion: December 31, 2011
• Study Completion: December 31, 2011
• Last Updated: August 14, 2023
• Results First Posted: January 28, 2021

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: July 2009
• Access Criteria: Public

Locations

US (2)