Clinical trial · Interventional
Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer
Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
NCT00100828CI-TRIAL-00036037terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Closed due to early stopping rule
Summary
Brief summary (as posted)
RATIONALE: Drugs used in chemotherapy, such as irinotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. PURPOSE: This phase II trial is studying how well irinotecan works in treating patients with metastatic or inoperable thyroid cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| irinotecan hydrochloride | Drug | Irinotecan | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Irinotecan
- interventionNames
- Drug: irinotecan hydrochloride
Primary outcomes (1)
- measure
- Response Rate
- timeFrame
- Every 2 cycles
- description
- To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
Inclusion * Histologically confirmed medullary thyroid cancer * Metastatic or inoperable locoregional disease * Measurable disease by CT scan * 18 years and over * ECOG PS 0-1 Adequate lab functions including: * Granulocyte count \> 1,000/mm\^3 * Platelet count \> 100,000/mm\^3 * Bilirubin \< 1.5 mg/dL * ALT and AST \< 2.5 times upper limit of normal * No unstable or uncompensated hepatic disease * Creatinine clearance \> 60 mL/min * No unstable or uncompensated renal disease * Negative pregnancy test * More than 3 months since prior biologic therapy * More than 3 months since prior chemotherapy * No prior radiotherapy to \> 25% of bone marrow * More than 3 months since prior radiotherapy * Recovered from prior oncologic or other major surgery * More than 30 days since prior non-approved or investigational drugs Exclusion: * Patients with elevated calcitonin levels as the only measurement of disease are not eligible * Unstable or uncompensated cardiovascular disease * Unstable or uncompensated respiratory disease * Pregnant or nursing * Diarrhea ≥ grade 2 (antidiarrheals allowed) * Other severe or uncontrolled systemic disease * Other malignancy within the past 5 years except squamous cell or basal cell skin cancer or cervical cancer * Illness that would preclude study participation * Significant clinical disorder or laboratory finding that would preclude study participation
References
Publications (0)
Data not yet available
No reference posted for this study.