Lenalidomide and Cetuximab in Patients With Advanced Solid Tumors

NCT01166035 | Unknown Phase 1

• 1 other identifier: TEXO0309
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This is a Phase 1/2, open-label, monocentric, dose-escalation study of lenalidomide in combination with cetuximab in subjects with solid tumors. The primary objective is to establish the maximum tolerated dose (MTD) of lenalidomide in combination with cetuximab in patients with solid tumors including colorectal cancer (CRC), squamous cell carcinoma of the head and neck (SCCHN) and non-small cell lung cancer (NSCLC).

Conditions

Solid Tumors

Keywords

Solid tumors; Lenalidomide; Cetuximab; Colorectal Cancer; Non-Small Cell Lung Cancer; Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose

  Determination of the maximum tolerated dose (MTD) of lenalidomide administered in combination with cetuximab. For each cohort of subjects (3 patients), the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Once 2 subjects have experienced DLT, enrollment at that dose will end and that dose will be declared to have exceeded the MTD.

  on the end of every treatment cycle (28 day-cycles).

Interventions

Lenalidomide DRUG

Lenalidomide will be supplied as 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration. Prior to Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Subjects will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28. For each cohort of subjects, the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Treatment will continue until the occurrence of any of the following events. * Disease progression * Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen. * Major violation of the study protocol. * Withdrawal of consent * Lost to follow up * Death * Suspected pregnancy

Cetuximab DRUG

Combination treatment will start at Day 1. Subjects meeting will be enrolled in cohorts of three to receive infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Cetuximab will be supplied as Erbitux® 22 mg/ml Vial à 50 ml, Erbitux 5 mg/ml Vial à 10 ml and Erbitux 5 mg/ml Vial à 50 ml for intravenous administration. Treatment will continue until the occurrence of any of the following events. * Disease progression * Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen. * Major violation of the study protocol. * Withdrawal of consent * Lost to follow up * Death * Suspected pregnancy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Disease Characteristics:
• Patients signed informed consent.
• Histologically or cytologically confirmed SCCHN, NSCLC, or metastatic colorectal adenocarcinoma.
• At least one unidimensionally measurable lesion.
• years of age.
• Eastern Cooperative Oncology Group (ECOG) performance status of \<= 1.
• Female subjects of childbearing potential must:
• Understand that the study medication could have an expected teratogenic risk
• Agree to use, and be able to comply with, effective contraception without interruption, 4 weeks before starting study drug, throughout study drug therapy (including dose interruptions) and for 4 weeks after the end of study drug therapy, even if she has amenorrhoea. An alternative would be an absolute and continued sexual abstinence.
• The following are effective methods of contraception\*
• Implant
• Levonorgestrel-releasing intrauterine system (IUS)\*\*
• Medroxyprogesterone acetate depot
• Tubal sterilisation
• Sexual intercourse with a vasectomised male partner only; vasectomy must be confirmed by two negative semen analyses Ovulation inhibitory progesterone-only pills (i.e., desogestrel)

You may not qualify if:

• Prior Treatment:
• Use of chemotherapy, hormonal therapy, immunotherapy, or any other anticancer or experimental therapy within 28 days prior to study medication.
• Active participation in another clinical trial.
• Radiotherapy within 28 days prior to study medication.
• Surgery within 28 days prior to study medication (minimally invasive procedures for the purpose of diagnosis or staging of the disease are permitted).
• Prior therapy with pomalidomide (CC-4047), lenalidomide, or thalidomide.
• Laboratory:
• Absolute neutrophil count (ANC) \< 1.5 x 109/L.
• Platelet count \< 100 x 109/L.
• Creatinine Clearance \< 50 mL/min.
• Bilirubin \> 1.5 x Upper Limit Normal (ULN) (\> 2.0 x ULN in the presence of Gilbert's Syndrome).
• Serum aspartate transaminase (AST)/SGOT \> 3.0 x ULN (\> 5 x ULN in the presence of liver metastases).
• Other Disease State:
• Untreated, symptomatic brain metastases (brain imaging not required).
• Venous thromboembolism within 6 months.

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Celgene Corporation: collaborator
• Innsbruck - Tyrolean Working Group of Experimental Oncology (TEXO): collaborator

Study Sites (1)

Medical University of Innsbruck, Department for Internal Medicine I

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (1)

• Gamerith G, Auer T, Amann A, Putzer D, Schenk B, Kircher B, Hilbe W, Zwierzina H, Loeffler-Ragg J. Increase in antibody-dependent cellular cytotoxicity (ADCC) in a patient with advanced colorectal carcinoma carrying a KRAS mutation under lenalidomide therapy. Cancer Biol Ther. 2014 Mar 1;15(3):266-70. doi: 10.4161/cbt.27327. Epub 2013 Dec 18.

  PMID: 24351336 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Head and Neck Neoplasms

Interventions

Lenalidomide; Cetuximab

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; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Heinz Zwierzina, Prof. Dr.

  Medical University of Innsbruck, Deparmtment of Internal Medicince I

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heinz Zwierzina, Prof. Dr.

CONTACT

0512 504 81427

Notfallaufnahme TILAK

CONTACT

0512 504 27057

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 19, 2010
• First Posted: July 20, 2010
• Study Start: March 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: December 1, 2011
• Last Updated: July 20, 2010

Record last verified: 2010-05

Locations

AU (1)