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A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer


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

Thank you

Trial Information

A Phase II Study of OSI-774 (Tarceva) in Combination With Oxaliplatin and Capecitabine in Previously Treated Patients With Stage IV Colorectal Cancer


Patients will be treated with OSI-774 (orally) daily, oxaliplatin (intravenously) every 3
weeks, and capecitabine (orally) twice daily for 14 days followed by a 7-day rest period.
This will constitute a 21-day treatment cycle. Treatment will continue until disease
progression or unacceptable toxicity occurs.


Inclusion Criteria:



- Ability to understand and the willingness to sign a written informed consent
document.

- Patients with histologic proof of adenocarcinoma of the colon or rectum (colorectal
carcinoma) with evidence of metastatic disease.

- Patients must have received one (and only 1) prior chemotherapy regimen for
metastatic disease. Patients who received adjuvant therapy and then 1 regimen for
metastatic disease are eligible. Patients who received adjuvant therapy and recur
within 12 months of completion of adjuvant therapy are also eligible.

- Patients who have received prior radiation therapy, either in the adjuvant or
metastatic setting, for colorectal carcinoma.

- All of the following must apply:

- Greater than 4 weeks must have elapsed from the time of major surgery and
patients must have recovered from the effects (e.g., laparotomy); *Greater than
2 weeks must have elapsed from the time of minor surgery and patients must have
recovered from the operation. (Insertion of a vascular access device is not
considered major or minor surgery.);

- Greater than 4 weeks must have elapsed from the time of major radiotherapy [RT]
(e.g., chest or bone palliative RT);

- Greater than 4 weeks must have elapsed from the completion of previous
chemotherapy and patients must have recovered from any related toxicities;

- Greater than 4 weeks must have elapsed from the participation in any
investigational drug study.

- ECOG performance status < 2 ; life expectancy > 12 weeks

- Patients must have normal organ and marrow function as defined below:

ANC > 1500/mm3; hemoglobin > 9.0 gm/dl; platelets > 100,000/mm3; SGOT < 2.5x upper
limits of normal if no evidence of liver metastases or < 5x upper limits of normal if
evidence of liver metastases; total bilirubin < 1.5x upper limits of normal; Alk Phos <
2.5x upper limits of normal (or < 5x upper limits of normal if evidence of liver
metastases or < 10x upper limits of normal if evidence of bone disease).

Exclusion Criteria:

- Patients with peripheral neuropathy of grade 2 or greater severity.

- Uncontrolled high blood pressure.

- Unstable angina.

- Symptomatic congestive heart failure.

- Myocardial infarction < 12 months prior to registration.

- Serious uncontrolled cardiac arrhythmia.

- New York Heart Association classification III or IV.

- Active or uncontrolled infection.

- Medical or psychiatric conditions which, in the opinion of the investigator, make
participation in an investigational trial of this nature a poor risk.

- Patients with known brain metastases or carcinomatous meningitis should be excluded
from this clinical trial because of their poor prognosis and because they often
develop progressive neurologic dysfunction that would confound the evaluation of
neurologic and other adverse events.

- No concurrent malignancy of any site, except for limited basal cell carcinoma or
squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

- Patients of childbearing potential must have a negative serum pregnancy test within 7
days prior to registration and agree to use an effective method of contraception.

- Patients who are pregnant or lactating.

- Patients with prior unanticipated severe reaction to fluoropyrimidine therapy, or
known sensitivity to 5-fluorouracil.

- Patients previously treated with oxaliplatin, OSI-774 or another epidermal growth
factor inhibitor (EGFR).

- Patients lacking physical integrity of the upper gastrointestinal tract.

- Patients with other serious uncontrolled medical conditions that the investigator
feels might compromise study participation.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the response rate of OSI-774 when given in combination with oxaliplatin and capecitabine in patients with previously-treated locally advanced, locally recurrent, or metastatic colorectal adenocarcinoma

Principal Investigator

Jeffrey A. Meyerhardt, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

02-269

NCT ID:

NCT00123851

Start Date:

March 2003

Completion Date:

August 2006

Related Keywords:

  • Colorectal Cancer
  • Neoplasm Metastasis
  • Colorectal
  • Metastatic Colorectal Cancer
  • Oxaliplatin
  • Tarceva
  • Capecitabine
  • Xeloda
  • Neoplasms
  • Colorectal Neoplasms
  • Neoplasm Metastasis

Name

Location

Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Dana-Farber Cancer InstituteBoston, Massachusetts  02115
Massachusetts General HospitalBoston, Massachusetts  02114-2617