Clinical trial NCT00345761: Clinical Study of Capecitabine, Oxaliplatin and Bevacizumab in Colorectal Cancer
Official title: Phase I/II Study of R340 (Capecitabine), L-OHP (Oxaliplatin) and R435 (Bevacizumab) in Advanced and/or Metastatic Colorectal Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Colorectal Cancer
Keywords: Advanced and/or metastatic colorectal cancer
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
Collaborators: name: Yakult Honsha Co., LTD
First posted: 2006-06-28
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the efficacy, safety and pharmacokinetics of capecitabine (2000 mg/m2/day by mouth \[po\], day 1 pm-day 15 am every 3 weeks \[q3w\]), oxaliplatin (130 mg/m2 intravenously \[iv\], day 1 q3w) and bevacizumab (7.5 mg/kg iv, day 1 q3w) in patients with advanced and/or metastatic colorectal cancer.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Response rate: Response Evaluation Criteria in Solid Tumors (RECIST)
timeFrame: event driven
measure: Safety (Common Terminology Criteria for Adverse Events [CTCAE] version 3.0)
timeFrame: throughout study
Secondary outcomes:
measure: time to progression
timeFrame: event driven
measure: overall survival
timeFrame: event driven
measure: time to response
timeFrame: event driven
measure: duration of response
timeFrame: event driven
measure: concentrations of R340 and its metabolites
timeFrame: throughout study
measure: concentrations of platinum
timeFrame: throughout study
measure: concentrations of bevacizumab
timeFrame: throughout study
measure: concentrations of vascular endothelial growth factor (VEGF)
timeFrame: throughout study
measure: concentrations of anti-bevacizumab antibody
timeFrame: throughout study
Other outcomes:
Locations:
city: Hokkaido
country: Japan
facility: Hokkaido Region
city: Kanto
country: Japan
facility: Kanto Region
city: Kinki
country: Japan
facility: Kinki Region
city: Tokai
country: Japan
facility: Tokai Region
Study officials:
affiliation: Clinical Development Department 3, Group 6
name: Yuji Hayashi
role: STUDY_CHAIR
References: