Head and Neck Cancer
Conditions
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
Sponsors
Study design
Eligibility
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
| Measure | Time frame | Description |
|---|---|---|
| Response Rate | Every 2 cycles | To determine the response rate of this regimen of irinotecan in patients with metastatic MTC |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Irinotecan irinotecan hydrochloride | 6 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 6 |
Baseline characteristics
| Characteristic | Irinotecan |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 71 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 type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 |
Outcome results
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.