Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

Johns Hopkins Medicine

Status and phase

Terminated

Phase 2

Conditions

Head and Neck Cancer

Treatments

Drug: irinotecan hydrochloride

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00100828

JHOC-J0459

CDR0000409567 (Other Identifier)

J0459

P30CA006973 (U.S. NIH Grant/Contract)

04-08-04-02 (Other Identifier)

P50CA096784 (U.S. NIH Grant/Contract)

JHOC-04080402

Details and patient eligibility

About

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.

Full 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.

Enrollment

6 patients

Sex

All

Ages

18 to 120 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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