Simvastatin and Panitumumab in Treating Patients With Advanced or Metastatic Colorectal Cancer

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Simvastatin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as panitumumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving simvastatin together with panitumumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well simvastatin given together with panitumumab works in treating patients with advanced or metastatic colorectal cancer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Leiden University Medical Center
• Treatments: Antibodies, Monoclonal; Panitumumab; Simvastatin

Criteria

DISEASE CHARACTERISTICS:

• Diagnosis of colorectal cancer

• Advanced or metastatic disease

• Failed prior fluorouracil-, oxaliplatin- and irinotecan-containing regimens

• In case of progressive disease within 6 months after start of adjuvant fluorouracil-, oxaliplatin-, and irinotecan-containing regimens, the adjuvant therapy is considered to be treatment for metastatic disease

• Mutant-type k-ras status (mutation in codon 12, 13, or 61) on tumor material

• Measurable disease according to RECIST criteria version 1.1

• Progressive disease in the past 3 months according to RECIST criteria version 1.1

• No symptomatic brain metastases, defined as any symptoms during the past 6 months

PATIENT CHARACTERISTICS:

• WHO performance status 0-2

• WBC ≥ 2.0 x 10^9/L

• ANC ≥ 1.5 x 10^9/L

• Platelet count ≥ 100 x 10^9/L

• Hemoglobin ≥ 9 g/dL

• Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)

• AST/ALT ≤ 3 times ULN (≤ 5 times ULN in case of liver metastases)

• Creatinine clearance ≥ 60 mL/min

• Magnesium normal

• Calcium normal

• Creatine phosphokinase ≤ 2.5 times ULN

• Not pregnant or nursing

• Not planning to become pregnant within 6 months after the end of study treatment

• Fertile patients must use highly effective contraception during and for 6 months after completion of study therapy

• No noncompliance in previous studies

• No alcohol use > 4 units/day or unwilling to abstain from use

• No history of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or signs of interstitial lung disease on baseline CT scan

• No clinically significant cardiovascular disease (including myocardial infarction, unstable angina, symptomatic congestive heart failure, or serious uncontrolled cardiac arrhythmia) < 1 year prior to study

• No symptomatic hypothyroidism

• No history of toxicity during statin use

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior EGFr-therapy, including monoclonal antibodies (e.g., panitumumab or cetuximab)

• No concurrent verapamil, amiodarone, or dronedarone or unwilling to abstain from use