Metastatic Colorectal Cancer
Conditions
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.
Detailed description
1. To evaluate the response rate of lapatinib and capecitabine combination in patients with metastatic colon or rectal cancer. 2. To evaluate the toxicity and tolerability of lapatinib and capecitabine in this population. 3. To determine overall survival and disease free survival of lapatinib and capecitabine.
Interventions
DRUGlapatinib
1250mg by mouth daily one hour before or after breakfast on a continuous basis.
DRUGCapecitabine
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.
Sponsors
GlaxoSmithKline
University of Wisconsin, Madison
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response Rate of Lapatinib/Capecitabine. | duration of study; on average 1 year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Capecitabine : 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.
lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis. | 29 |
| Total | 29 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 16 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 4 / 29 |
Outcome results
Primary
Response Rate of Lapatinib/Capecitabine.
Time frame: duration of study; on average 1 year
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Lapatinib/Capecitabine | Response Rate of Lapatinib/Capecitabine. | PD | 4 participants |
| Lapatinib/Capecitabine | Response Rate of Lapatinib/Capecitabine. | SD | 1 participants |