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Phase II Study Evaluating the Combination of 5-Fluorouracil, Leucovorin, Oxaliplatin, and Herceptin in the Treatment of Patients With Metastatic Colorectal Cancer Who Have Progressed After 5-FU and/or Irinotecan-Containing Therapy

Phase 2
18 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Phase II Study Evaluating the Combination of 5-Fluorouracil, Leucovorin, Oxaliplatin, and Herceptin in the Treatment of Patients With Metastatic Colorectal Cancer Who Have Progressed After 5-FU and/or Irinotecan-Containing Therapy


- Determine the response rate of patients who overexpress HER-2/neu with metastatic
colorectal adenocarcinoma who have progressed on at least 1 prior, but no more than 2
prior, chemotherapy regimens for metastatic colorectal cancer treated with
fluorouracil, leucovorin calcium, oxaliplatin, and trastuzumab (Herceptin).

- Determine the time to progression of these patients treated with this regimen.

- Determine the overall toxicity of this regimen in these patients.

OUTLINE: Patients receive trastuzumab (Herceptin) IV over 30-90 minutes on days 1, 8, 15,
and 22, followed by oxaliplatin IV over 2 hours on days 1 and 15, and then followed by
leucovorin calcium IV over 2 hours on days 1, 8, and 15. Fluorouracil IV is administered at
the midpoint of the leucovorin calcium infusion on days 1, 8, and 15. Treatment continues
every 28 days in the absence of unacceptable toxicity or disease progression.

PROJECTED ACCRUAL: A total of 20-45 patients will be accrued for this study.

Inclusion Criteria


- 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+



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,000/mm3


- Bilirubin no greater than 2.0 mg/dL

- AST no greater than 2.5 times upper limit of normal


- Creatinine normal OR

- Creatinine clearance at least 60 mL/min


- No history of cardiac ischemia or congestive heart failure

- LVEF at least 50% by ECG or MUGA


- 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


Biologic therapy:

- Not specified


- 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


- At least 3 weeks since prior radiotherapy and recovered


- Not specified

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response rate

Outcome Time Frame:

Every 2 tx cycles

Safety Issue:


Principal Investigator

Jeffrey W. Clark, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital


United States: Federal Government

Study ID:




Start Date:

May 2000

Completion Date:

February 2003

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • adenocarcinoma of the colon
  • adenocarcinoma of the rectum
  • Colorectal Neoplasms



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