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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Swiss Group for Clinical Cancer Research
ClinicalTrials.gov Identifier:
NCT00544700
First received: October 13, 2007
Last updated: December 10, 2013
Last verified: December 2013

October 13, 2007
December 10, 2013
October 2007
May 2012   (final data collection date for primary outcome measure)
Time to progression [ Time Frame: From randomization until documented progressive disease or death due to tumor. ] [ Designated as safety issue: No ]
Time to progression
Complete list of historical versions of study NCT00544700 on ClinicalTrials.gov Archive Site
  • Overall survival [ Time Frame: OS will be calculated from start of first-line treatment until death. Additionally, OS will be calculated from randomization until death. ] [ Designated as safety issue: No ]
  • Progression-free survival PFS [ Time Frame: From start of first-line treatment until documented PD or death, whichever occurs first. ] [ Designated as safety issue: No ]
  • Adverse events (AE) [ Time Frame: Predefined AEs and AEs ≥ grade 3 will be assessed according to NCI CTCAE v3.0. ] [ Designated as safety issue: Yes ]
  • Long-term bevacizumab treatment costs [ Time Frame: Estimated for the time period between randomization and the end of the follow-up phase (lasting maximal 5 years). ] [ Designated as safety issue: No ]
  • Overall survival
  • Progression-free survival
  • Adverse events
  • Long-term bevacizumab treatment costs
Not Provided
Not Provided
 
Bevacizumab in Treating Patients Who Have Undergone First-Line Therapy for Metastatic Colorectal Cancer
Bevacizumab Maintenance Versus no Maintenance After Stop of First-line Chemotherapy in Patients With Metastatic Colorectal Cancer. A Randomized Multicenter Phase III Non-inferiority Trial

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.

OBJECTIVES:

Primary

  • To demonstrate that time to progression (TTP) without further treatment is not inferior to TTP with maintenance therapy comprising bevacizumab in patients with metastatic colorectal cancer and stable or responding disease after completion of standard first-line chemotherapy/bevacizumab treatment.

Secondary

  • To evaluate the safety of bevacizumab maintenance therapy in these patients.
  • To assess the long-term cost implications of prolonged treatment with bevacizumab.

OUTLINE: This is a multicenter study. Patients are stratified according to best response during first-line chemotherapy/bevacizumab treatment (complete response and partial response vs stable disease), duration of first-line treatment (16-20 weeks vs 21-24 weeks), type of chemotherapy used during first-line treatment (irinotecan and fluoropyrimidine vs oxaliplatin and fluoropyrimidine vs fluoropyrimidine monotherapy), disease burden (one organ with metastasis vs more than one organ with metastasis), and by participating center.

  • Arm I (bevacizumab maintenance therapy): Patients receive bevacizumab IV over 30 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
  • Arm II (no maintenance therapy): Patients receive no further treatment; they are monitored for disease progression.

After completion of study therapy or documentation of disease progression, patients are followed every 3 months for 1 year and then every 6 months for up to 5 years.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Biological: bevacizumab
    7.5 mg/kg i.v. bevacizumab every 21 days until progression or unacceptable toxicity
    Other Name: Avastin®
  • Other: no maintenance
    No treatment until progression
  • Active Comparator: Arm A: Bevacizumab monotherapy
    Bevacizumab maintenance monotherapy
    Intervention: Biological: bevacizumab
  • Arm B: No maintenance
    No antitumor treatment until progression
    Intervention: Other: no maintenance
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
265
December 2017
May 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT00544700
SAKK 41/06, SWS-SAKK-41/06, EU-20762, CDR0000569866
No
Swiss Group for Clinical Cancer Research
Swiss Group for Clinical Cancer Research
Not Provided
Study Chair: Dieter Koeberle, MD Cantonal Hospital of St. Gallen
Study Chair: Peter Moosmann, MD Kantonsspital Aarau
Swiss Group for Clinical Cancer Research
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP