A Study of Avastin (Bevacizumab) in Combination With Xelox and Tarceva in Patients With Metastatic Colorectal Cancer.

NCT01135498 | Completed Phase 2 Results

• 1 other identifier: ML19875
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 12

Brief Summary

This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Disease Progression or Death

  Disease progression was defined according to Response Evaluation Criteria in Solid Tumors (RECIST) as a 20 percent (%) increase in the sum of the longest diameter of target lesions, or a measureable increase in a non-target lesion, or the appearance of new lesions.

  Start of study to approximately 4 years

• Progression-Free Survival

  Progression-free survival was defined as the time from the date of informed consent until the date when the participant had progression of disease or died from disease progression. Participants who received surgical treatment after treatment ended were censored at the time of surgery. Participants who left the study for reasons other than progression of the disease were censored on the date on which they received a later antitumor therapy (with the same or different drugs, radiotherapy, or surgery).

  From study start up to approximately 4 years

Secondary Outcomes (4)

• Percentage of Participants Achieving Objective Response (Complete Response [CR] or Partial Response [PR])

  From study start up to approximately 4 years

• Percentage of Participants Achieving Disease Control (CR, PR, or No Change [NC])

  From study start up to approximately 4 years

• Percentage of Participants Who Died

  From study start up to approximately 4 years

• Overall Survival (OS)

  From study start up to approximately 4 years

Study Arms (1)

1

EXPERIMENTAL

Drug: bevacizumab [Avastin]; Drug: eloxatin; Drug: capecitabine [Xeloda]; Drug: erlotinib [Tarceva]

Interventions

bevacizumab [Avastin] DRUG

Intravenous repeating dose

1

eloxatin DRUG

Intravenous repeating dose

1

capecitabine [Xeloda] DRUG

Oral repeating dose

1

erlotinib [Tarceva] DRUG

Oral repeating dose

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;
• adenocarcinoma of colon or rectum, with metastatic disease;
• \>=1 measurable lesion.

You may not qualify if:

• previous treatment with Avastin or Tarceva;
• previous systemic treatment for advanced or metastatic disease;
• adjuvant treatment for non-metastatic disease in past 6 months.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (12)

Unknown Facility

Palma de Mallorca, Balearic Islands, 07198, Spain

Location

Unknown Facility

Sabadell, Barcelona, Barcelona, 08208, Spain

Location

Unknown Facility

Terrassa, Barcelona, 08221, Spain

Location

Unknown Facility

Burgos, Burgos, 09006, Spain

Location

Unknown Facility

Santander, Cantabria, 39008, Spain

Location

Unknown Facility

Huesca, Huesca, 22004, Spain

Location

Unknown Facility

Jaén, Jaen, 23007, Spain

Location

Unknown Facility

Logroño, La Rioja, 26006, Spain

Location

Unknown Facility

Lleida, Lerida, 25198, Spain

Location

Unknown Facility

Teruel, Teruel, 44002, Spain

Location

Unknown Facility

Barakaldo, Vizcaya, 48903, Spain

Location

Unknown Facility

Zaragoza, Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Oxaliplatin; Capecitabine; Erlotinib Hydrochloride

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; Coordination Complexes; Organic Chemicals; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

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: June 1, 2010
• First Posted: June 2, 2010
• Study Start: November 1, 2006
• Primary Completion: April 1, 2010
• Study Completion: April 1, 2010
• Last Updated: February 6, 2015
• Results First Posted: February 6, 2015

Record last verified: 2015-01

Locations

ES (12)