Combination Chemotherapy Plus Trastuzumab in Treating Patients With Advanced, Recurrent, or Metastatic Colorectal Cancer

• Status: Terminated
• Trial end date: 2003-02-01
• Target enrollment: 0
• Participant gender: All

Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.

PURPOSE: This phase II trial is studying combination chemotherapy plus trastuzumab to see how well it works in treating patients with advanced, recurrent, or metastatic colorectal cancer.

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

Details

• Lead Sponsor: National Cancer Institute (NCI)
• Treatments: Calcium; Fluorouracil; Leucovorin; Levoleucovorin; Oxaliplatin; Trastuzumab

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed advanced, recurrent, or metastatic colorectal adenocarcinoma

• Resected CNS metastases stable greater than 1 month after completion of radiotherapy for CNS metastases eligible

• No existing CNS metastases allowed

• Measurable disease

• At least 1 dimension as at least 20 mm with conventional techniques OR

• At least 10 mm with spiral CT scan

• No truly nonmeasurable lesions:

• Bone lesions

• Leptomeningeal disease

• Lymphangitis cutis/pulmonis

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• Must have progressed on at least 1 prior, but no more than 2 prior, fluorouracil and/or irinotecan containing treatment regimens for metastatic colorectal cancer

• Must have documented HER-2/neu overexpression by immunohistochemistry staining

• Staining score at least 2+

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• Not specified

Hematopoietic:

• Granulocyte count at least 1,500/mm3

• Platelet count at least 100,000/mm3

Hepatic:

• Bilirubin no greater than 2.0 mg/dL

• AST no greater than 2.5 times upper limit of normal

Renal:

• Creatinine normal OR

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No history of cardiac ischemia or congestive heart failure

• LVEF at least 50% by ECG or MUGA

Other:

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No concurrent second malignancy except nonmelanoma skin cancers or carcinoma in situ of the cervix unless completed therapy and considered to be at less than 30% risk of relapse

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics

• No prior platinum containing chemotherapy

• At least 3 weeks since prior chemotherapy and recovered

• No other concurrent chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• At least 3 weeks since prior radiotherapy and recovered

Surgery:

• Not specified