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Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.


Phase 3
18 Years
N/A
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

Avastin and Chemotherapy Followed by Avastin Alone or in Combination With Tarceva for the Treatment of Metastatic Colorectal Cancer.


Patients with metastatic colorectal cancer will be treated with standard chemotherapy
according to the investigators choice. In addition to chemotherapy, Avastin (bevacizumab)
will be given during the treatment period. After the chemotherapy is finished (after 18
weeks), maintenance therapy will be given and the patients will be randomized to treatment
with either with Avastin alone or Avastin in combination with Tarceva (erlotinib). Patients
with progressive disease, or patients suitable to curative resection of metastases will be
taken out of study.


Inclusion Criteria:



1. Adenocarcinoma of the colon or rectum.

2. Age > 18.

3. Measurable disease according to RECIST criteria.

4. Expected survival more than three months.

5. Adequate bone marrow, liver and kidney function.

6. INR < 1.5 times upper limit.

7. Adequate contraception for fertile patients.

8. Signed written informed consent.

Exclusion Criteria:

1. Earlier chemotherapy for metastatic colorectal cancer.

2. Adjuvant treatment within 6 months.

3. Surgery or significant trauma within 28 days prior to study entry.

4. Planned radiotherapy against target lesions.

5. CNS metastases.

6. Prior malignancy within 5 years except ca in situ of cervix and basal cell carcinoma.

7. Bleeding diathesis

8. Uncontrolled hypertension.

9. Significant cardiovascular disease.

10. Treatment with anticoagulant drugs.

11. Participation in other clinical trial.

12. Pregnant or lactating.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

progression-free survival

Outcome Time Frame:

3 years

Safety Issue:

Yes

Principal Investigator

Anders Johnsson, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Lund University Hospital Sweden

Authority:

Sweden: Medical Products Agency

Study ID:

ML19033

NCT ID:

NCT00598156

Start Date:

June 2007

Completion Date:

August 2012

Related Keywords:

  • Metastatic Colorectal Cancer
  • Colorectal Neoplasms

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