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Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer

Phase 1/Phase 2
20 Years
74 Years
Not Enrolling
Colorectal Cancer

Thank you

Trial Information

Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer

This study will evaluate the efficacy, safety and pharmacokinetics of Capecitabine (2000
mg/m2/day po, day 1 pm-day 15 am q3w), Oxaliplatin (130 mg/m2 iv, day 1 q3w) and Bevacizumab
(7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Inclusion Criteria:

- Adult patients 20-74 years of age

- Histologically confirmed colorectal cancer

- Metastatic and/or locally advanced colorectal cancer not previously treated with
chemotherapy for metastatic disease

- At least one measurable lesion according to RECIST

Exclusion Criteria:

- Evidence of clinically detectable ascites at study treatment start

- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
prior to study treatment start, or anticipation of the need for major surgical
procedure during the course of the study; fine needle aspiration within 7 days prior
to study treatment start.

- Evidence of bleeding diathesis or coagulopathy

- Serious, non-healing wound, ulcer, or bone fracture

- Chronic, daily aspirin (> 325 mg/day), anticoagulants, or other medications known to
predispose to gastrointestinal ulceration

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: Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Time Frame:

event driven

Safety Issue:


Principal Investigator

Yuji Hayashi

Investigator Role:

Study Chair

Investigator Affiliation:

Clinical Development Department 3, Group 6


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

February 2006

Completion Date:

July 2010

Related Keywords:

  • Colorectal Cancer
  • Advanced and/or metastatic colorectal cancer
  • Colorectal Neoplasms