Trial · NCT00729157
Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
NCT00729157, Phase 2, Completed, National Cancer Institute (NCI); results first posted 2017-03-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy. Trials, record NCT00729157. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00729157
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aflibercept in Treating Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy
- NCT number
- NCT00729157
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 41 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- 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
- Interventions
- Fludeoxyglucose F-18, Laboratory Biomarker Analysis, Pharmacological Study, Positron Emission Tomography, Ziv-Aflibercept
- First posted
- 2008-08-07
- Last updated
- 2017-03-15
- Results first posted
- 2017-03-15
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate | 6 months | Progression-free survival to determine the 6-month progression-free-survival (PFS) rate |
| Primary | Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy | After 8 weeks of study 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 |
| Secondary | 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 | The number of participants, with recurrent and/or metastatic TC-FCO, who experienced adverse events. Please see the adverse event table for the specifics for this protocol. |
| Secondary | 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 | 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. |
| Secondary | Effect of Thyroglobulin Concentration on Progression-free Survival | 6 months | The change is serum thyroglobulin was measured by the percent change between the baseline value and the lowest value obtained while on treatment. |
| Other | 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 | This part is currently under data analysis, therefore, this outcome measure has not been calculatedThis part is currently under data analysis, therefore, this outcome measure has not been calculated. |
| Other | 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 | This part is currently under data analysis, therefore, this outcome measure has not been calculated |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate | 6 months | months | MEDIAN | |
| PRIMARY | Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy | After 8 weeks of study therapy | participants | NUMBER | |
| SECONDARY | 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 | participants | NUMBER | |
| SECONDARY | 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 | percent of SUVm change | MEDIAN | |
| SECONDARY | Effect of Thyroglobulin Concentration on Progression-free Survival | 6 months | percent change serum thyroglobulin | MEDIAN | |
| OTHER_PRE_SPECIFIED | 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 | |||
| OTHER_PRE_SPECIFIED | 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 |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival to Determine the 6-month Progression-free-survival (PFS) Rate | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 5.4 | 95% Confidence Interval 1.6 to 30.8 | months | |
| Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | Progression of Disease | 7 | participants | |
| Radiographic Response Rate of Aflibercept in Patients With Recurrent and/or Metastatic Thyroid Cancer That Did Not Respond to Radioactive Iodine Therapy | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | Stable Disease | 33 | participants | |
| The Safety and Toxicity Profile of IV VEGF Trap in Patients With Recurrent and/or Metastatic TC-FCO | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 36 | participants | ||
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. | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | .64 | 95% Confidence Interval -6.91 to 12.67 | percent of SUVm change | |
| Effect of Thyroglobulin Concentration on Progression-free Survival | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 0.4 | Full Range 0 to 90 | percent change serum thyroglobulin |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 41 | |
| Overall Study | COMPLETED | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 40 | |
| Overall Study | NOT COMPLETED | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 1 |
Source ClinicalTrials.gov
Adverse events64
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anemia | Blood and lymphatic system disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 2 | 41 | 4 |
| other | Anorexia | Metabolism and nutrition disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 4 | 41 | 4 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 7 | 41 | 11 |
| other | Blood bilirubin increased | Investigations | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 4 | 41 | 11 |
| other | Bone pain | Musculoskeletal and connective tissue disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 2 | 41 | 2 |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 5 | 41 | 6 |
| other | Dysphagia | Gastrointestinal disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 3 | 41 | 3 |
| other | Fatigue | General disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 8 | 41 | 13 |
| other | Headache | Nervous system disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 6 | 41 | 8 |
| other | Hyperglycemia | Metabolism and nutrition disorders | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 14 | 41 | 70 |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | ||
| Total, other adverse events | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 36 | 41 |
| Total, serious adverse events | Treatment (Ziv-aflibercept and Fludeoxyglucose F 18) | 24 | 41 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants1
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P30CA008748 | Cancer Center Support Grant | Rudin, Charles M. | SLOAN-KETTERING INST CAN RESEARCH | NATIONAL CANCER INSTITUTE | 1985 to 2026 |
Source NIH RePORTER
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00729157
GET https://conductscience.org/api/trials/v1/NCT00729157/events?page=2