Phase II Trial of Lapatinib & Capecitabine for Patients With Refractory Advanced Colorectal Adenocarcinoma

NCT00574171 | Completed Phase 2 Results DMC

• 5 other identifiers: CO 07201A534260SMPH\MEDICINE\HEM-ONCLAP109859NCI-2011-00477
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out how effective this combination is as a second line treatment for colorectal cancer that has spread from one part of the body to another (metastasized) or has not metastasized but is considered inoperable (unable to be removed by surgery). The side effects and survival experienced by subjects receiving these drugs will also be evaluated. This is a phase II research study.

Conditions

Metastatic Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

• Response Rate of Lapatinib/Capecitabine.

  duration of study; on average 1 year

Study Arms (1)

1

EXPERIMENTAL

Drug: lapatinib; Drug: Capecitabine

Interventions

lapatinib DRUG

1250mg by mouth daily one hour before or after breakfast on a continuous basis.

Also known as: Tykerb

1

Capecitabine DRUG

2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.

Also known as: Xeloda

1

Eligibility Criteria

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

You may qualify if:

• Age \> 18 years
• Pathologically confirmed, locally advanced or metastatic adenocarcinoma of the colon or rectum
• Patients must have had progression of disease on prior therapy with an oxaliplatin-containing or irinotecan containing regimen
• Proper radiographic documentation of measurable disease using RECIST criteria
• ECOG performance status (PS) of 0 or 1
• Laboratory parameters:
• Hgb: ≥ 9.0 g/dl ANC ≥ 1500/ul Platelet ≥ 100,000/ul Creatinine ≤ 2x ULN OR Creatinine clearance ≥ 30 mg/ml Bilirubin ≤ 2x ULN AST ≤ 2x ULN or 5X ULN if liver metastases are present
• Patient has signed informed consent
• Toxicities from prior therapy (except alopecia and neuropathy) must have resolved to grade 1 or better prior to enrollment

You may not qualify if:

• Administration of more than one prior systemic chemotherapy for metastatic disease
• Pregnant or breast-feeding women: female patients must agree to use effective contraception, must be surgically sterile, or must be postmenopausal. Male patients must agree to use effective contraception or be surgically sterile. The definition of effective contraception will be based on the judgment of the principal investigator or a designated associate. All at-risk female patients must have a negative serum pregnancy test within 7 days prior to randomization.
• Active inflammatory bowel disease, significant bowel obstruction, or chronic diarrhea (grade 2).
• Known human immunodeficiency virus (HIV) positivity or acquired-immunodeficiency-syndrome (AIDS)-related illness.
• No previous or concurrent malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in-situ cervical cancer, or other cancer for which the patient has been disease-free for 3 years.
• Known CNS metastases
• Prior therapy which specifically and directly targets the EGFR pathway
• Significant history of uncontrolled cardiovascular disease, defined as:
• History of uncontrolled or symptomatic angina
• History of arrhythmias requiring medications, or clinically significant, with the exception of asymptomatic atrial fibrillation requiring anticoagulation
• Myocardial infarction \< 6 months prior to study entry
• Cerebrovascular accident \<6 months prior to study entry
• Uncontrolled or symptomatic congestive heart failure
• Ejection fraction below the institutional normal limit
• Any other cardiac condition, which in the opinion of the treating physician, would make this protocol unreasonably hazardous for the patient

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

University of Wisconsin Paul P. Carbone Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Lapatinib; Capecitabine

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)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Dr. William Schelman
• Organization: UW Carbone Cancer Center

wrs@medicine.wisc.edu

608-265-4347

Study Officials

• Alcee J Jumonville, M.D.

  Gunderson Lutheran - LaCrosse

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2007
• First Posted: December 17, 2007
• Study Start: September 1, 2007
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: December 18, 2019
• Results First Posted: July 14, 2015

Record last verified: 2016-02

Locations

US (1)