Status:
TERMINATED
Everolimus in Treating Patients With Advanced or Metastatic Colorectal Cancer That Did Not Respond to Previous Therapy
Lead Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. PURPOSE: This phase II trial is studying how w...
Detailed Description
OBJECTIVES: * Determine response rate, time to tumor progression, and survival of patients with advanced or metastatic refractory colorectal cancer and mutations in the PI3K gene treated with everoli...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Cytologically or pathologically confirmed colorectal adenocarcinoma
- Advanced or metastatic disease
- Refractory to ≥ 1 line of prior therapy
- Not amenable to potentially curative surgical resection
- Mutations in the PI3K gene in tumor tissue
- Tumor tissue available for genetic testing OR willing to undergo baseline tumor biopsy
- Tumor amenable to sequential biopsies
- Willing to undergo 2 sequential tumor biopsies, and 2 sequential skin biopsies
- Measurable lesion with ≥ 1 diameter ≥ 2 cm by conventional CT scan (1 cm by spiral CT scan) in a nonirradiated area
- No known brain metastases
- PATIENT CHARACTERISTICS:
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- Life expectancy \> 12 weeks
- WBC ≥ 3,000/mm³
- Absolute neutrophil count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin normal
- AST and ALT ≤ 2.5 times upper limit of normal (ULN)
- Creatinine normal OR creatinine clearance ≥ 60 mL/min
- Cholesterol and triglycerides ≤ 2.5 times ULN
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to everolimus
- No uncontrolled intercurrent illness, including, but not limited to, any of the following:
- Hypertension
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would preclude study compliance
- No evidence of bleeding diathesis
- Able to swallow tablets
- PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since prior radiotherapy or chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
- No prior targeted therapy against mTOR
- No other concurrent investigational agents
- No concurrent therapeutic anticoagulation
- Prophylactic anticoagulation (i.e., low-dose warfarin) of venous or arterial access devices allowed provided the requirements for PT, INR or PTT are met.
- No concurrent combination antiretroviral therapy for HIV-positive patients
- No other concurrent anticancer therapy, including chemotherapy, hormonal therapy, immunotherapy, alternative therapy, or radiotherapy
- No concurrent live vaccination
Exclusion
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00390364
Start Date
October 1 2006
End Date
October 1 2007
Last Update
October 8 2014
Active Locations (1)
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1
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410