Monoclonal Antibody Plus Chemotherapy in Treating Patients With Advanced Colorectal Cancer That Overexpresses HER2

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

Summary

Phase II trial to study the effectiveness of the monoclonal antibody trastuzumab and chemotherapy with irinotecan in treating patients who have stage IV colorectal cancer that overexpresses HER2. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody therapy with chemotherapy may kill more tumor cells.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Irinotecan; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed stage IV colorectal cancer with p185 HER2 overexpression

• Bidimensionally measurable disease Indicator lesion must be outside of irradiated field No symptomatic CNS brain metastases

PATIENT CHARACTERISTICS:

• Performance status: ECOG 0-2

• Absolute granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)

• SGOT no greater than 3.0 times ULN

• Creatinine no greater than 2.0 mg/dL

• LVEF at least 45% by MUGA or ECHO

• No myocardial infarction within the past 6 months

• No congestive heart failure

• No unstable angina

• No clinically significant pericardial effusion or arrhythmia

• Not pregnant or nursing

• Negative pregnancy test

• Fertile patients must use effective contraception during and for 6 months after study

• No other prior malignancy within the past 5 years, except:

• Curatively treated basal or squamous cell skin cancer

• Curatively treated carcinoma in situ of the cervix

• No active serious infection or serious underlying medical condition that would prevent compliance

• No dementia or significantly altered mental status

PRIOR CONCURRENT THERAPY:

• Concurrent filgrastim (G-CSF), sargramostim (GM-CSF), or epoetin alfa allowed

• No prior trastuzumab

• No more than 1 prior chemotherapy regimen for advanced disease (if progressed during or within 6 months of adjuvant therapy considered to have had 1 regimen for advanced disease)

• No prior irinotecan

• Concurrent contraception, estrogen replacement therapy, or megestrol acetate for anorexia allowed

• Greater than 3 weeks since prior radiotherapy and recovered

• Greater than 3 weeks since major surgery (except simple biopsy or venous access placement) and recovered

• At least 3 weeks since prior investigational nonneoplastic drugs