Molecular Profiling Protocol (SCRI-CA-001)

Early Phase 1

Completed

• Conditions: Refractory Cancer

• Registration Number: NCT00530192
• Lead Sponsor: Scottsdale Healthcare

Brief Summary

This is an open-label, multicenter pilot study in patients with advanced solid tumors.

The primary objective of this study is to compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.

To be eligible, patients must have received at least two lines of prior chemotherapeutic, hormonal or biological regimens for advanced disease, have measurable or evaluable, refractory disease and have clear documentation of the time between treatment start and documented progression on the last treatment prior to study entry. Eligible patients must undergo or have available a tumor biopsy for molecular profiling within 2 months of IHC/FISH and/or DNA microarray analysis.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2007-09-14
• Study First Submitted QC: 2007-09-14
• Study First Posted: 2007-09-17
• Primary Completion: 2009-03
• Study Completion: 2009-03
• Status Verified: 2009-07
• Last Update Submitted: 2009-07-09
• Last Update Posted: 2009-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

Inclusion Criteria

• Metastatic cancer which has progressed on 2 prior chemotherapeutic, hormonal or biological regimens for advanced disease.
• Be defined as refractory to the last line of therapy
• Have documentation of the best clinical response to the treatment regimen immediately prior to entering this study

Exclusion Criteria

• Patients with symptomatic CNS metastasis
• Any previous history of another malignancy within 5 years of study entry
• Uncontrolled intercurrent illness
• Known HIV, HBV, HCV infection
• Pregnant or breast-feeding

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To compare progression-free survival using a treatment regimen selected by molecular profiling with progression-free survival for the most recent regimen the patient has progressed on.	Every 8 weeks disease assessments are performed

Secondary Outcome Measures

Name	Time	Method
To determine the frequency with which molecular profiling of a patient's tumor by IHC/FISH and/or microarray analysis yields a target against which there is a commercially available, approved therapeutic regimen.	Time of Profiling- Baseline
To determine the response rate (according to RECIST or disease-specific response criteria) and the percent of patients with non-progression at 4 months in patients with solid tumors whose therapy is selected by molecular profiling.	4 months

Trial Locations

Locations (9)

Tower Oncology; 🇺🇸 Beverly Hills, California, United States

Central Indiana Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Louis Warschaw Prostate Cancer Center at Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Oncology Specialties; 🇺🇸 Huntsville, Alabama, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

Cancer Center of the Carolinas; 🇺🇸 Greenville, South Carolina, United States

South Texas Oncology Hematology; 🇺🇸 San Antonio, Texas, United States

Tyler Cancer Center; 🇺🇸 Tyler, Texas, United States

TGen Clinical Research Services; 🇺🇸 Scottsdale, Arizona, United States