Irinotecan in Treating Patients With Metastatic or Inoperable Thyroid Cancer

• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00100828
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 6
• Locations: 2
• Arm: 1
• Duration (Months): 48
• Patients Per Site: 3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: irinotecan hydrochloride	Phase 2

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Phase II Trial of Irinotecan for Treatment of Metastatic Medullary Thyroid Cancer
• Study Start Date: Nov 1, 2004
• Actual Primary Completion Date: Nov 1, 2008
• Actual Study Completion Date: Nov 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Irinotecan	Drug: irinotecan hydrochloride

Outcome Measures

Primary Outcome Measures

1. Response Rate [Every 2 cycles]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 120 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins	Baltimore	Maryland	United States	21231-2410
2	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan	United States	48109-0942

Sponsors and Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• National Cancer Institute (NCI)

Investigators

• Study Chair: Arlene A. Forastiere, MD, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Clinical trial summary from the National Cancer Institute's PDQ® database

Publications

None provided.

• Responsible Party: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• ClinicalTrials.gov Identifier: NCT00100828
• Other Study ID Numbers: J0459; P50CA096784; P30CA006973; JHOC-J0459; JHOC-04080402; CDR0000409567; 04-08-04-02
• First Posted: Jan 7, 2005
• Last Update Posted: Dec 6, 2018
• Last Verified: Nov 1, 2018

• Keywords provided by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: thyroid gland medullary carcinoma; recurrent thyroid cancer
• Additional relevant MeSH terms: Thyroid Neoplasms; Irinotecan

Study Results

Participant Flow

Arm/Group Title	Irinotecan
Arm/Group Description	irinotecan hydrochloride
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Irinotecan
Arm/Group Description	irinotecan hydrochloride
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	4 66.7%
>=65 years	2 33.3%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71 (10.94)
Sex: Female, Male (Count of Participants)
Female	2 33.3%
Male	4 66.7%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Response Rate
Description	To determine the response rate of this regimen of irinotecan in patients with metastatic MTC
Time Frame	Every 2 cycles

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Irinotecan
Arm/Group Description	irinotecan hydrochloride
Measure Participants	0

Adverse Events

Arm/Group Title	Irinotecan
Arm/Group Description	irinotecan hydrochloride
All Cause Mortality
	Irinotecan
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Irinotecan
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Irinotecan
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.