Bevacizumab in Treating Patients Who Have Undergone First-Line Therapy for Metastatic Colorectal Cancer

NCT00544700 | Terminated Phase 3 DMC

• 4 other identifiers: SAKK 41/06SWS-SAKK-41/06EU-20762CDR0000569866
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 29

Brief Summary

RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. It is not yet known whether giving bevacizumab as maintenance therapy is more effective than observation in treating patients with colorectal cancer. PURPOSE: This randomized phase III trial is studying bevacizumab to see how well it works in treating patients who have undergone first-line therapy for metastatic colorectal cancer.

Conditions

Colorectal Cancer

Keywords

stage IV colon cancer; stage IV rectal cancer

Outcome Measures

Primary Outcomes (1)

• Time to progression (TTP)

  TTP will be calculated from randomization until documented PD or death due to tumor.

  From randomization until documented progressive disease or death due to tumor.

Secondary Outcomes (4)

• Overall survival (OS)

  OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death.

• Progression-free survival (PFS)

  From start of first-line treatment until documented PD or death, whichever occurs first.

• Adverse events (AE)

  Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0.

• Long-term bevacizumab treatment costs

  Estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years).

Study Arms (2)

Arm A: Bevacizumab monotherapy

ACTIVE COMPARATOR

Bevacizumab maintenance monotherapy

Biological: bevacizumab

Arm B: No maintenance

OTHER

No antitumor treatment until progression

Other: no maintenance

Interventions

bevacizumab BIOLOGICAL

7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity

Also known as: Avastin®

Arm A: Bevacizumab monotherapy

no maintenance OTHER

No treatment until progression

Arm B: No maintenance

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic colorectal cancer * Received prior first-line chemotherapy with oral or intravenous fluoropyrimidine alone or in combination with irinotecan or oxaliplatin * Chemotherapy must have been given in combination with a standard dose of bevacizumab for 16-24 weeks as part of first-line treatment for metastatic colorectal cancer * Stable disease, partial response, or complete response after completion of first-line treatment as documented by abdominal and thoracic CT scan, MRI, or x-ray within the past 21 days * No clinical symptoms or history of CNS metastases * No imaging required in asymptomatic patients PATIENT CHARACTERISTICS: * WHO performance status 0-1 * Serum creatinine \< 2.0 mg/dL or 177 μmol/L * Proteinuria \< 2+ by urine dipstick OR urine protein ≤ 1 g by 24-hour urine collection * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 12 months after completion of study therapy * Must have basic health insurance with a Swiss health insurance company * Patients must be compliant and in geographic proximity to allow proper staging and follow-up * No medical reason that prohibits further bevacizumab treatment, including any of the following: * Uncontrolled hypertension (systolic blood pressure \[BP\] \> 150 mm Hg and/or diastolic BP \> 100 mm Hg) or clinically significant (i.e., active) cardiovascular disease * Serious non-healing wound, active peptic ulcer, or non-healing bone fracture * History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months * History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding * No serious underlying medical condition that, in the judgment of the investigator, could further impair the ability of the patient to participate in the trial (e.g., active autoimmune disease or uncontrolled diabetes) * No psychiatric disorder that would preclude patient understanding of study-related topics or giving informed consent PRIOR CONCURRENT THERAPY: * See Disease Characteristics * At least 4 weeks since prior bevacizumab * No prior anti-EGFR treatment (e.g., cetuximab) during first-line therapy * No anticipation of concurrent major surgery (e.g., resection) or ablation of metastases * No concurrent elective major surgery * No concurrent daily aspirin exceeding 325 mg/day or clopidogrel exceeding 75 mg/day * Lower doses of the drugs noted above, or non-steroidal anti-inflammatory drugs with activity on platelets and gastric mucosa, or dipyridamole are allowed if given at a stable dose for ≥ 2 weeks prior to study entry * No other concurrent experimental drugs or anticancer therapy

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Swiss Cancer Institute: lead

Study Sites (29)

Kantonsspital Aarau

Aarau, CH-5000, Switzerland

Location

Hirslanden Klinik Aarau

Aarau, CH-5001, Switzerland

Location

Kantonsspital Baden

Baden, CH-5404, Switzerland

Location

St. Claraspital AG

Basel, CH-4016, Switzerland

Location

Universitaetsspital-Basel

Basel, CH-4031, Switzerland

Location

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Bellinzona, 6500, Switzerland

Location

Inselspital, Bern

Bern, CH-3010, Switzerland

Location

Spitalzentrum Biel

Biel, CH-2501, Switzerland

Location

Kantonsspital Bruderholz

Bruderholz, CH-4101, Switzerland

Location

Spital Buelach

Bülach, CH-8180, Switzerland

Location

AndreasKlinik Cham Zug

Cham, CH-6330, Switzerland

Location

Kantonsspital Graubuenden

Chur, CH-7000, Switzerland

Location

Hopital Fribourgeois

Fribourg, 1708, Switzerland

Location

Hopital Cantonal Universitaire de Geneve

Geneva, CH-1211, Switzerland

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Kantonsspital Liestal

Liestal, CH-4410, Switzerland

Location

Istituto Oncologico della Svizzera Italiana

Lugano, CH-6900, Switzerland

Location

Kantonsspital Luzern

Luzerne, CH-6000, Switzerland

Location

Onkologie Zentrum am Spital Maennedorf

Männedorf, 8708, Switzerland

Location

Kantonsspital Olten

Olten, CH-4600, Switzerland

Location

Kantonsspital - St. Gallen

Sankt Gallen, CH-9007, Switzerland

Location

Hopital Regional de Sion-Herens-Conthey

Sion, CH -1951, Switzerland

Location

Regionalspital

Thun, 3600, Switzerland

Location

Spital Uster

Uster, 8610, Switzerland

Location

Kantonsspital Winterthur

Winterthur, CH-8400, Switzerland

Location

Onkozentrum Klinik im Park

Zurich, 8038, Switzerland

Location

Klinik Hirslanden

Zurich, CH-8008, Switzerland

Location

Stadtspital Waid

Zurich, CH-8037, Switzerland

Location

UniversitaetsSpital Zuerich

Zurich, CH-8091, Switzerland

Location

Related Publications (1)

• Koeberle D, Betticher DC, von Moos R, Dietrich D, Brauchli P, Baertschi D, Matter K, Winterhalder R, Borner M, Anchisi S, Moosmann P, Kollar A, Saletti P, Roth A, Frueh M, Kueng M, Popescu RA, Schacher S, Hess V, Herrmann R. Bevacizumab continuation versus no continuation after first-line chemotherapy plus bevacizumab in patients with metastatic colorectal cancer: a randomized phase III non-inferiority trial (SAKK 41/06). Ann Oncol. 2015 Apr;26(4):709-714. doi: 10.1093/annonc/mdv011. Epub 2015 Jan 20.

  PMID: 25605741 DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms; Colonic Neoplasms; Rectal Neoplasms

Interventions

Bevacizumab

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

Study Officials

• Dieter Koeberle, MD

  St. Claraspital Basel

  STUDY CHAIR

• Peter Moosmann, MD

  Kantonsspital Aarau

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2007
• First Posted: October 16, 2007
• Study Start: November 26, 2007
• Primary Completion: January 21, 2013
• Study Completion: December 12, 2019
• Last Updated: February 20, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

CH (29)