A Study of Avastin (Bevacizumab) and Oxaliplatin Plus Xeloda (Capecitabine) in Patients With Advanced Colorectal Cancer.

NCT01159171 | Completed Phase 2 Results

• 1 other identifier: ML18523
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 6

Brief Summary

This study will assess the efficacy and safety of treatment with the combination Avastin (bevacizumab) 5mg/kg iv every 2 weeks, Xeloda (capecitabine) 1000 mg po b.i.d. on Days 1-14 of every 28-day cycle and oxaliplatin 40mg/m2 iv weekly in patients with inoperable locally advanced or metastatic colorectal cancer. The anticipated time on study treatment is until disease progression.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Objective Response (OR)

  Percentage of participants with OR was defined as the percentage of participants who achieved complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR was defined as greater than or equal to (≥)30 percent (%) decrease under baseline of the sum of the longest diameter (LD) diameters of all target lesions. No unequivocal progression of non-target disease. No new lesions. Complete and partial responses must have been confirmed no less than 4 weeks after the criteria for response were first met.

  Baseline, every 3 months to progression of disease or end of study (up to 24 months)

• Percentage of Participants by Best Overall Response

  Best response recorded from the start of treatment until disease progression. Based on assessment of CR, PR, stable disease (SD), or progressive disease (PD), according to RECIST. CR: disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. PR: ≥30% decrease under baseline of the sum of the LD diameters of all target lesions. CR and PR persist on repeat imaging study at least 4 weeks after initial documentation. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Reference is the smallest sum LD. PD: at least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum longest diameter recorded or the appearance of one or more new lesions.

  Baseline, every 3 months to progression of disease or end of study (up to 24 months)

Secondary Outcomes (10)

• Duration of Response - Percentage of Participants With an Event by 24 Months

  Baseline, every 3 months to progression of disease or end of study (up to 24 months)

• Duration of Response

  Baseline, every 3 months to progression of disease or end of study (up to 24 months)

• Duration of Stable Disease - Percentage of Participants With an Event by 24 Months

  Baseline, every 3 months to progression of disease or end of study (up to 24 months)

• Duration of Stable Disease

  Baseline, every 3 months to progression of disease or end of study (up to 24 months)

• Time to Treatment Failure (TTF) - Percentage of Participants With an Event by 24 Months

  Baseline, every month to end of treatment (up to 24 months)

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: capecitabine [Xeloda]; Drug: oxaliplatin

Interventions

bevacizumab [Avastin] DRUG

5 mg/kg intravenously every 14 days

1

capecitabine [Xeloda] DRUG

1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle

1

oxaliplatin DRUG

40 mg/m2 iv weekly

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients \>=18 years of age
• Locally advanced or metastatic colorectal cancer
• No previous treatment with chemotherapy for metastatic disease
• Measurable and/or evaluable lesions

You may not qualify if:

• Radiotherapy within 4 weeks before study
• Untreated brain metastases or primary brain tumors
• Chronic, daily treatment with high-dose aspirin (\>325mg/day)
• Co-existing malignancies, or malignancies diagnosed within the last 5 years, with the exception of basal and squamous cell cancer, or cervical cancer in situ

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (6)

Unknown Facility

Aviano, 33081, Italy

Location

Unknown Facility

Fano, 61032, Italy

Location

Unknown Facility

Palermo, 90146, Italy

Location

Unknown Facility

Rimini, 47900, Italy

Location

Unknown Facility

Roma, 00135, Italy

Location

Unknown Facility

Torino, 10126, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Oxaliplatin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Coordination Complexes; Organic Chemicals

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann-LaRoche

genentech@druginfo.com

800-821-8590

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2010
• First Posted: July 9, 2010
• Study Start: January 1, 2006
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

IT (6)