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

NCT01110785 | Unknown Phase 2

• 6 other identifiers: CDR0000671002DUT-LUMC-30012009EUDRACT-2009-014452-30EU-21033DUT-LUMC-RASTAT-PNL-29611-058-09
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Colorectal Cancer

Keywords

recurrent colon cancer; stage III colon cancer; stage IV colon cancer; recurrent rectal cancer; stage III rectal cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of patients free from progression and alive at 11 weeks after the first dose of panitumumab measured by RECIST v 1.1

Secondary Outcomes (9)

• Toxicity measured by NCICTC v 3.0

• Median and mean overall survival

• Median and mean progression-free survival

• Objective response rate

• Correlation between skin toxicity and response to treatment

Interventions

panitumumab BIOLOGICAL

simvastatin DRUG

laboratory biomarker analysis OTHER

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Leiden University Medical Center: lead

Study Sites (4)

Reinier de Graaf Group - Delft

Delft, 2625 AD, Netherlands

RECRUITING

Leiden University Medical Center

Leiden, 2333 ZA, Netherlands

RECRUITING

Diaconessenhuis Leiden

Leiden, 2334 CK, Netherlands

RECRUITING

HagaZiekenhuis - Locatie Leyenburg

The Hague, 2545 CH, Netherlands

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Panitumumab; Simvastatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Hans Gelderblom, MD, PhD

  Leiden University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 23, 2010
• First Posted: April 27, 2010
• Study Start: April 1, 2010
• Primary Completion: April 1, 2012
• Last Updated: September 17, 2013

Record last verified: 2011-04

Locations

NL (4)