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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00100828
Other study ID # J0459
Secondary ID P50CA096784P30CA
Status Terminated
Phase Phase 2
First received
Last updated
Start date November 2004
Est. completion date November 2008

Study information

Verified date November 2018
Source Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender All
Age group 18 Years to 120 Years
Eligibility 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

Study Design


Intervention

Drug:
irinotecan hydrochloride


Locations

Country Name City State
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore Maryland

Sponsors (2)

Lead Sponsor Collaborator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Response Rate To determine the response rate of this regimen of irinotecan in patients with metastatic MTC Every 2 cycles
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