11C Topotecan PET Imaging

Lung Cancer Clinical Trial

Official title:

Positron Emission Tomography Using 11C Topotecan in Predicting Response to Treatment in Patients With Brain Metastases Due to Ovarian, Small Cell Lung, or Other Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00253461
• Other study ID #: CWRU6Y02
• Secondary ID: P30CA043703CASE-
• Status: Terminated
• Phase: Phase 0
• First received: November 11, 2005
• Last updated: March 16, 2012
• Start date: December 2004
• Est. completion date: November 2009

Study information

• Verified date: March 2012
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

RATIONALE: Diagnostic procedures, such as positron emission tomography (PET scan) using 11C topotecan, may help doctors predict a patient's response to treatment and help plan the best treatment.

PURPOSE: This phase I/II trial is studying how well a PET scan using 11C topotecan predicts response to treatment in patients with brain metastases due to ovarian, small cell lung, or other cancer.

Description:

OBJECTIVES:

Primary

• Determine if tumor uptake of ^11C topotecan occurs quickly enough and at sufficient concentration to be measured immediately following infusion in patients with brain metastases secondary to ovarian cancer, small cell lung cancer, or other cancers.

• Determine, preliminarily, if ^11C imaging has potential to be an early predictor of response to topotecan therapy in these patients.

Secondary

• Determine the whole-body biodistribution of ^11C topotecan in these patients.

OUTLINE:

• Phase I: Patients receive ^11C topotecan IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Within 4 weeks after initial imaging, patients also undergo a CT scan.

• Phase II: Patients receive ^11C topotecan and undergo imaging as in phase I. Patients also receive fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Histologically confirmed ovarian cancer, small cell lung cancer, or other cancers

• Metastatic brain disease

• Eligible for topotecan therapy

• Measurable disease by CT scan and/or MRI

PATIENT CHARACTERISTICS:

Performance status

• ECOG 0-2

Life expectancy

• More than 3 months

Hematopoietic

• WBC = 3,000/mm^3

• Platelet count = 100,000/mm^3

Hepatic

• Not specified

Renal

• Creatinine clearance = 50 mL/min

Other

• Not pregnant or nursing

• Adequate end-organ function

• Able to tolerate lying on a radiology table for = 1 hour

• No serious medical or psychiatric illness that would preclude study compliance or giving informed consent

PRIOR CONCURRENT THERAPY: Not specified

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Lung Cancer
• Metastatic Cancer
• Neoplasm Metastasis
• Ovarian Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Procedure:
• computed tomography
Within 4 weeks after initial imaging, patients also undergo a CT scan.
• positron emission tomography
Phase I: IV over 10 minutes followed immediately by a 1-2 hour positron emission tomography (PET) scan. Phase II: fludeoxyglucose F 18 IV and, 1 hour later, undergo a PET scan.

Radiation:
• 11C topotecan
Phase I and II: IV over 10 minutes
• fludeoxyglucose F 18
Phase II: fludeoxyglucose F 18 IV

Locations

Country	Name	City	State
United States	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetics on day of positron-emission tomography scan		Within 1 week of PET	No
Primary	Disease response		after 1-2 courses of treatment	No