A Study of Avastin (Bevacizumab) in Combination Chemotherapy in Patients With Metastatic Cancer of the Colon or Rectum

NCT01131078 | Completed Phase 2 Results

• 1 other identifier: ML18524
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 44

Brief Summary

A study of Avastin (bevacizumab) in combination chemotherapy in patients with metastatic cancer of the colon or rectum. The anticipated time on study treatment is until disease progression.

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (2)

• Percentage of Participants With Disease Progression or Death

  Disease progression was defined according to National Cancer Institute (NCI) guidelines and best clinical practices.

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

• Time to Progression (TTP)

  TTP is defined as the time from date of randomization until objective tumor progression or death due to any cause. It includes deaths and thus can be correlated to overall survival.

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Secondary Outcomes (15)

• Percentage of Participants Who Died

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

• Overall Survival

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

• Percentage of Participants With Treatment Failure

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

• Time to Treatment Failure

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

• Percentage of Participants With Progression Excluding Deaths

  Randomization, Weeks 3, 6 and 9, and every 3 months up to 5 years or Death

Study Arms (3)

Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)

EXPERIMENTAL

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle. Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks. Capecitabine was administered orally at a dose of 1000 mg/m\^2 twice daily (Day 2 to 15). Cycle length was 3 weeks consisting of 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.

Drug: Bevacizumab [Avastin]; Drug: Capecitabine; Drug: Irinotecan

Bevacizumab + Capecitabine (1250 mg/m^2)

EXPERIMENTAL

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle in combination with capecitabine administered orally at 1250 mg/m\^2 twice daily (Day 1 to 14). Cycle length was 3 weeks with 2 weeks of capecitabine treatment followed by 1 week without treatment up to 6 cycles. After 6 cycles, participants with objective response or SD were treated with bevacizumab alone until unacceptable toxicity, PD, or participant withdrawal.

Drug: Bevacizumab [Avastin]; Drug: Capecitabine

Bevacizumab + Capecitabine (650 mg/m^2)

EXPERIMENTAL

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 Week cycle in combination with capecitabine administered orally at 650 mg/m\^2 twice daily (Day 1 to 21). Cycle length was 3 weeks with 3 weeks of capecitabine treatment without interruptions. Participants received the same regimen until unacceptable toxicity, PD, or participant withdrawal.

Drug: Bevacizumab [Avastin]; Drug: Capecitabine

Interventions

Bevacizumab [Avastin] DRUG

Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle.

Also known as: Avastin

Bevacizumab + Capecitabine (1250 mg/m^2); Bevacizumab + Capecitabine (650 mg/m^2); Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)

Capecitabine DRUG

Capecitabine was administered orally at a doses of 1000 or 1250, mg/m\^2 twice daily (Day 2 to 15) or as 650 mg/m\^2 twice daily on Days 1 to 21.

Bevacizumab + Capecitabine (1250 mg/m^2); Bevacizumab + Capecitabine (650 mg/m^2); Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)

Irinotecan DRUG

Irinotecan was administered as a 240 mg/m\^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.

Bevacizumab + Irinotecan + Capecitabine (1000 mg/m^2)

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;
• colon or rectal cancer, with metastases;
• \>=1 measurable lesion.

You may not qualify if:

• previous systemic treatment for advanced disease;
• radiotherapy to any site within 4 weeks before study;
• daily aspirin (\>325 mg/day), anticoagulants, or other medications known to predispose to gastrointestinal ulceration;
• co-existing malignancies or malignancies diagnosed within last 5 years (except basal cell cancer or cervical cancer in situ).

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (44)

Unknown Facility

Paola, Calabria, 87027, Italy

Location

Unknown Facility

Benevento, Campania, 82100, Italy

Location

Unknown Facility

Napoli, Campania, 80136, Italy

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Carpi, Emilia-Romagna, 41012, Italy

Location

Unknown Facility

Piacenza, Emilia-Romagna, 29100, Italy

Location

Unknown Facility

Latisana, Friuli Venezia Giulia, 33053, Italy

Location

Unknown Facility

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Unknown Facility

Latina, Lazio, 04100, Italy

Location

Unknown Facility

Rome, Lazio, 00168, Italy

Location

Unknown Facility

Rome, Lazio, 00186, Italy

Location

Unknown Facility

Brescia, Lombardy, 25123, Italy

Location

Unknown Facility

Busto Arsizio, Lombardy, 21052, Italy

Location

Unknown Facility

Casalpusterlengo, Lombardy, 20071, Italy

Location

Unknown Facility

Cremona, Lombardy, 26100, Italy

Location

Unknown Facility

Gorgonzola, Lombardy, 20064, Italy

Location

Unknown Facility

Lecco, Lombardy, 23900, Italy

Location

Unknown Facility

Legnago, Lombardy, 37045, Italy

Location

Unknown Facility

Mantova, Lombardy, 46100, Italy

Location

Unknown Facility

Milan, Lombardy, 20121, Italy

Location

Unknown Facility

Milan, Lombardy, 20133, Italy

Location

Unknown Facility

Milan, Lombardy, 20142, Italy

Location

Unknown Facility

Milan, Lombardy, 20162, Italy

Location

Unknown Facility

Pavia, Lombardy, 27100, Italy

Location

Unknown Facility

Saronno, Lombardy, 21047, Italy

Location

Unknown Facility

Sondrio, Lombardy, 23100, Italy

Location

Unknown Facility

Treviglio, Lombardy, 24047, Italy

Location

Unknown Facility

Varese, Lombardy, 21100, Italy

Location

Unknown Facility

Novara, Piedmont, 28100, Italy

Location

Unknown Facility

Turin, Piedmont, 10153, Italy

Location

Unknown Facility

Cagliari, Sardinia, 09100, Italy

Location

Unknown Facility

Catania, Sicily, 95100, Italy

Location

Unknown Facility

Palermo, Sicily, 90127, Italy

Location

Unknown Facility

Ancona, The Marches, 60121, Italy

Location

Unknown Facility

Bolzano, Trentino-Alto Adige, 39100, Italy

Location

Unknown Facility

Florence, Tuscany, 50139, Italy

Location

Unknown Facility

Grosseto, Tuscany, 58100, Italy

Location

Unknown Facility

Pisa, Tuscany, 56100, Italy

Location

Unknown Facility

Prato, Tuscany, 59100, Italy

Location

Unknown Facility

Terni, Umbria, 05100, Italy

Location

Unknown Facility

Camposampiero, Veneto, 35012, Italy

Location

Unknown Facility

Este, Veneto, 35042, Italy

Location

Unknown Facility

Montecchio Maggiore, Veneto, 36075, Italy

Location

Unknown Facility

Negrar, Veneto, 37024, Italy

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Bevacizumab; Capecitabine; Irinotecan

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; Camptothecin; Alkaloids

Results Point of Contact

• Title: Medical Communications
• Organization: Hoffmann- LaRoche

genentech@druginfo.com

1-800-821-8590

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2010
• First Posted: May 26, 2010
• Study Start: June 1, 2005
• Primary Completion: November 1, 2012
• Study Completion: November 1, 2012
• Last Updated: June 4, 2015
• Results First Posted: December 31, 2014

Record last verified: 2015-06

Locations

IT (44)