Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

NCT00729157 | Completed Phase 2 Results DMC

• 7 other identifiers: NCI-2009-00178MSKCC-08066CDR000060816308-0667508N01CM62206P30CA008748
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial is studying how well aflibercept works in treating patients with recurrent and/or metastatic thyroid cancer that has not responded to radioactive iodine therapy. Aflibercept may stop the growth of tumor cells by blocking blood flow to the tumor and by carrying tumor-killing substances directly to thyroid cancer cells.

Conditions

Recurrent Thyroid Gland Carcinoma; Stage III Thyroid Gland Follicular Carcinoma; Stage III Thyroid Gland Papillary Carcinoma; Stage IV Thyroid Gland Follicular Carcinoma; Stage IV Thyroid Gland Papillary Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate

  Progression-free survival to determine the 6-month progression-free-survival (PFS) rate

  6 months

• Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions \& assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + P RMeasurable lesions are defined as those that can be accurately measured in at least one dimension (longest diameter to be recorded) as ≥ 20 mm with conventional techniques (CT, MRI, x-ray) or as ≥ 10 mm with spiral CT scan. All tumor measurements must be recorded in millimeters (or decimal fractions of centimeters). All other lesions (or sites of disease), including small lesions (longest diameter \< 20 mm with conventional techniques or \< 10 mm using spiral CT scan), are considered non-measurable disease. Bone lesions, leptomeningeal disease, ascites, pleural/pericardial effusions, lymphangitis cutis/pulmonis, inflammatory breast disease, abdominal masses (not followed by CT or MRI), \& cystic

  After 8 weeks of study therapy

Secondary Outcomes (3)

• The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO

  From the beginning of treatment through 30 days until participant comes off study

• To Determine the Biologic Effect of IV VEGF Trap on FDG Avidity After Four Cycles (Approximately 8 Weeks) of Therapy Through Pre- and Post-treatment FDG-PET Scans in Patients With Recurrent and/or Metastatic D-TC-FCO.

  8 weeks

• Effect of Thyroglobulin Concentration on Progression-free Survival

  6 months

Other Outcomes (2)

• To Determine if Pre-treatment Serum VEGF Concentration Correlates With Clinical Outcomes After IV VEGF Trap Therapy in Patients With Recurrent and/or Metastatic D-TC-FCO.

  Baseline-6 months post treatment

• To Determine if Changes in Thyroglobulin Concentration After Four Cycles (Approximately 8 Weeks) of IV VEGF-Trap Therapy Correlate With Radiographic Response After Four Cycles (Approximately 8 Weeks)

  8 weeks

Study Arms (1)

Treatment (ziv-aflibercept and fludeoxyglucose F 18)

EXPERIMENTAL

Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days for up to 12 months in the absence of disease progression or unacceptable toxicity. Patients experiencing clear clinical benefit with aflibercept may continue treatment beyond 12 months, at the discretion of the study sponsor. Patients undergo FDG-PET scans at baseline and after 8 weeks of study therapy to evaluate changes in FDG avidity on FDG-PET scan. Blood samples are obtained at baseline and periodically during study for laboratory correlative studies. Samples are examined for pretreatment serum VEGF concentration, thyroglobulin levels (when elevated), serum pharmacokinetics of aflibercept by ELISA, and anti-aflibercept antibodies.

Radiation: Fludeoxyglucose F-18; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Procedure: Positron Emission Tomography; Biological: Ziv-Aflibercept

Interventions

Fludeoxyglucose F-18 RADIATION

Correlative studies

Also known as: 18FDG, FDG, fludeoxyglucose F 18, Fludeoxyglucose F18, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, Fluorodeoxyglucose F18

Treatment (ziv-aflibercept and fludeoxyglucose F 18)

Laboratory Biomarker Analysis OTHER

Correlative studies

Treatment (ziv-aflibercept and fludeoxyglucose F 18)

Pharmacological Study OTHER

Correlative studies

Treatment (ziv-aflibercept and fludeoxyglucose F 18)

Positron Emission Tomography PROCEDURE

Correlative studies

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET SCAN, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging

Treatment (ziv-aflibercept and fludeoxyglucose F 18)

Ziv-Aflibercept BIOLOGICAL

Given IV

Also known as: AFLIBERCEPT, AVE0005, Vascular Endothelial Growth Factor Trap, VEGF Trap, VEGF Trap R1R2, VEGF-Trap, Zaltrap

Treatment (ziv-aflibercept and fludeoxyglucose F 18)

Eligibility Criteria

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

You may qualify if:

• Histopathologically confirmed differentiated thyroid carcinoma of follicular cell origin, including any of the following histologies and their respective variants:
• Papillary
• Follicular
• Hürthle cell
• Must have surgically inoperable and/or recurrent or metastatic disease
• At least one fludeoxyglucose F 18 (FDG)-PET-avid lesion, defined as any focus of increased FDG uptake \> normal mediastinal activity with standard uptake variable (SUV) maximum levels ≥ 3, as documented by baseline PET scan
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques or ≥ 10 mm by spiral CT scan
• Progressive disease, defined by ≥ 1 of the following occurring during or after prior treatment (e.g., radioactive isotope \[RAI\] treatment):
• Presence of new or progressive lesions on CT scan or MRI
• New lesions on bone scan or PET scan
• Rising thyroglobulin level documented by a minimum of 3 consecutive rises, with an interval of \> 1 week between each determination
• No known history of brain metastasis
• ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
• ANC ≥ 1,500/mcL
• Platelet count ≥ 75,000/mcL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Adenocarcinoma, Follicular; Thyroid Cancer, Papillary

Interventions

Fluorodeoxyglucose F18; Magnetic Resonance Spectroscopy; aflibercept

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma, Papillary

Intervention Hierarchy (Ancestors)

Deoxyglucose; Deoxy Sugars; Carbohydrates; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Results Point of Contact

• Title: Dr. David Pfister
• Organization: Memorial Sloan Kettering Cancer Center

pfisterd@mskcc.org

646-888-4237

Study Officials

• David Pfister

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 6, 2008
• First Posted: August 7, 2008
• Study Start: August 1, 2008
• Primary Completion: October 1, 2012
• Study Completion: November 1, 2012
• Last Updated: March 15, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-01

Locations

US (1)