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Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00100828
Enrollment
6
Registered
2005-01-07
Start date
2004-11-30
Completion date
2008-11-30
Last updated
2018-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Keywords

thyroid gland medullary carcinoma, recurrent thyroid cancer

Brief summary

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.

Detailed description

OBJECTIVES: Primary * Determine the response rate in patients with metastatic or inoperable locoregional medullary thyroid cancer treated with irinotecan. Secondary * Determine the safety and tolerability of this drug in these patients. OUTLINE: Patients receive irinotecan IV on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Response is assessed after completion of 4 courses. Patients achieving complete response (CR) or partial response (PR) receive 2 additional courses beyond CR or PR. Patients who have stable disease receive up to 12 total courses. PROJECTED ACCRUAL: A total of 33 patients will be accrued for this study.

Interventions

DRUGirinotecan hydrochloride

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Response RateEvery 2 cyclesTo determine the response rate of this regimen of irinotecan in patients with metastatic MTC

Countries

United States

Participant flow

Participants by arm

ArmCount
Irinotecan
irinotecan hydrochloride
6
Total6

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyPhysician Decision6

Baseline characteristics

CharacteristicIrinotecan
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
2 Participants
Age, Categorical
Between 18 and 65 years
4 Participants
Age, Continuous71 years
STANDARD_DEVIATION 10.94
Region of Enrollment
United States
6 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 6
serious
Total, serious adverse events
0 / 6

Outcome results

Primary

Response Rate

To determine the response rate of this regimen of irinotecan in patients with metastatic MTC

Time frame: Every 2 cycles

Population: Study was closed to enrollment due to low accrual. Data was not collected for this outcome measure.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026