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An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

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Trial Information

An Open Label Phase II Clinical Trial To Evaluate The Safety And Efficacy Of ABX-EGF In Patients With Metastatic Colorectal Carcinoma


OBJECTIVES:

- Determine the response rate of patients with metastatic colorectal cancer treated with
monoclonal antibody ABX-EGF.

- Determine the additional measures of clinical efficacy of this drug, in terms of
progression-free survival, overall survival, and time to treatment failure, in these
patients.

- Determine the safety of this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive monoclonal antibody ABX-EGF IV over 1 hour weekly on weeks 1-8. Treatment
repeats every 8 weeks for up to 6 courses in the absence of disease progression or
unacceptable toxicity.

Patients are followed at 4 weeks, every 3 months for 1 year, and then every 6 months for 1
year.

PROJECTED ACCRUAL: A total of 20-100 patients will be accrued for this study.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed colorectal carcinoma

- Diagnosed by fine-needle aspirate or tissue biopsy

- Metastatic disease

- No squamous cell carcinoma

- Relapsed or refractory after prior chemotherapy with irinotecan and a
fluoropyrimidine (i.e., fluorouracil, capecitabine, or ftorafur with or without
leucovorin calcium) given concurrently or sequentially

- Progressive disease within 2 months of last dose of this prior chemotherapy for
metastatic disease OR

- Evidence of relapse within 12 months after last dose of adjuvant therapy

- Bidimensionally measurable disease

- Overexpression of epidermal growth factor r (EGFr) by immunohistochemistry

- Must be 2+ or 3+ in at least 10% of evaluated tumor cells

- No known brain metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Absolute neutrophil count greater than 1,500/mm3

- Platelet count greater than 100,000/mm3

Hepatic:

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

- AST and ALT no greater than 3 times ULN

- Alkaline phosphatase no greater than 3 times ULN

Renal:

- Creatinine no greater than 2.2 mg/dL

Cardiovascular:

- LVEF at least 45% by MUGA

- No myocardial infarction within the past year

Other:

- HIV negative

- No other malignancy within the past 5 years except basal cell carcinoma or carcinoma
in situ of the cervix

- No chronic medical or psychiatric condition that would preclude study

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 1 month after study

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- No prior EGFr-targeting agents or biological agents with antitumor activity

Chemotherapy:

- See Disease Characteristics

- At least 30 days since prior systemic chemotherapy

- No more than 2 prior fluoropyrimidine regimens (e.g., fluorouracil and leucovorin
calcium followed by capecitabine)

- No other prior chemotherapy, except leucovorin calcium, for colorectal carcinoma

Endocrine therapy:

- Not specified

Radiotherapy:

- At least 30 days since prior radiotherapy

Surgery:

- Not specified

Other:

- At least 30 days since other prior anticancer therapy

- No prior investigational drug with potential antitumor activity

- No other concurrent investigational drugs

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Joel Randolph Hecht, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Jonsson Comprehensive Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000069368

NCT ID:

NCT00039273

Start Date:

July 2002

Completion Date:

Related Keywords:

  • Colorectal Cancer
  • stage IV colon cancer
  • stage IV rectal cancer
  • recurrent colon cancer
  • recurrent rectal cancer
  • Colorectal Neoplasms

Name

Location

Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781