OPAL Study: A Study of Avastin (Bevacizumab) in Combination With FOLFOXIRI in Patients With Previously Untreated Metastatic Colorectal Cancer

NCT00940303 | Completed Phase 2

• 2 other identifiers: ML205142008-001180-11
• Study Type: interventional
• Target: 97
• Locations: 1 country
• Sites: 17

Brief Summary

This single arm study will assess progression-free survival, feasibility of use and safety of Avastin in combination with 5-FU/FA, oxaliplatin and irinotecan (FOLFOXIRI) as first line treatment in patients with metastatic colorectal cancer. Patients will receive up to 12 bi-weekly cycles of Avastin (5mg/kg iv) in combination with this standard neoadjuvant chemotherapy regimen followed by up to 40 bi-weekly cycles with Avastin plus 5-FU/FA. 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 (1)

• Progression-free survival

  assessed every 8 weeks up to week 102, 3-monthly during follow-up

Secondary Outcomes (2)

• Overall survival; proportion of patients achieving R0 resectability; objective response rate (complete response [CR] and partial response [PR]); proportion of patients completing 12 cycles of chemotherapy.

  assessed every 4 weeks up to week 102 and at the end of follow-up period

• Proportion of patients with NCI-CTC grade 3-5 adverse events; adverse events, laboratory parameters, ECOG performance status.

  Throughout study, laboratory analyses every 2 weeks, ECOG assessment every 8 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: 5-FU; Drug: bevacizumab [Avastin]; Drug: irinotecan; Drug: leucovorin; Drug: oxaliplatin

Interventions

5-FU DRUG

3200mg/m2 continuous iv infusions, day 1 every 2 weeks

1

bevacizumab [Avastin] DRUG

5mg/kg iv infusion, day 1 every 2 weeks

1

irinotecan DRUG

165mg/m2 iv infusion, day 1 every 2 weeks

1

leucovorin DRUG

200mg/m2 iv infusion, day 1 every 2 weeks

1

oxaliplatin DRUG

85mg/m2 iv infusion, day 1 every 2 weeks

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, 18-70 years of age;
• metastatic colorectal cancer scheduled for standard first line chemotherapy;
• at least 1 measurable lesion;
• ECOG performance score of 0 or 1.

You may not qualify if:

• prior chemotherapy for metastatic colorectal cancer;
• prior (neo)adjuvant chemotherapy/radiotherapy of a non-metastatic malignancy completed within 6 months prior to study entry;
• concomitant malignancies other CRC;
• history or evidence of CNS disease unrelated to cancer.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (17)

Unknown Facility

Berlin, 10117, Germany

Location

Unknown Facility

Berlin, 13347, Germany

Location

Unknown Facility

Bochum, 44791, Germany

Location

Unknown Facility

Celle, 29221, Germany

Location

Unknown Facility

Celle, 29223, Germany

Location

Unknown Facility

Dessau, 06847, Germany

Location

Unknown Facility

Freiburg im Breisgau, 79106, Germany

Location

Unknown Facility

Fulda, 36043, Germany

Location

Unknown Facility

Hamburg, 20246, Germany

Location

Unknown Facility

Hamburg, 22087, Germany

Location

Unknown Facility

Hanover, 30171, Germany

Location

Unknown Facility

Leer, 26789, Germany

Location

Unknown Facility

Magdeburg, 39120, Germany

Location

Unknown Facility

Magdeburg, 39130, Germany

Location

Unknown Facility

Nuremberg, 90419, Germany

Location

Unknown Facility

Stade, 21680, Germany

Location

Unknown Facility

Villingen-Schwenningen, 78052, Germany

Location

Related Publications (1)

• Stein A, Atanackovic D, Hildebrandt B, Stubs P, Brugger W, Hapke G, Steffens CC, Illerhaus G, Bluemner E, Stohlmacher J, Bokemeyer C. Upfront FOLFOXIRI+bevacizumab followed by fluoropyrimidin and bevacizumab maintenance in patients with molecularly unselected metastatic colorectal cancer. Br J Cancer. 2015 Sep 15;113(6):872-7. doi: 10.1038/bjc.2015.299. Epub 2015 Sep 3.

  PMID: 26335608 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Fluorouracil; Bevacizumab; Irinotecan; Leucovorin; 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)

Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Camptothecin; Alkaloids; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes; Organic Chemicals

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

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 6, 2009
• First Posted: July 16, 2009
• Study Start: June 1, 2009
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

DE (17)