STEAM: A Study of Sequential and Concurrent FOLFOXIRI/Avastin (Bevacizumab) Regimens Versus FOLFOX/Avastin in First-Line in Patients With Metastatic Colorectal Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01765582
First received: January 9, 2013
Last updated: July 7, 2014
Last verified: July 2014

January 9, 2013
July 7, 2014
January 2013
December 2017   (final data collection date for primary outcome measure)
  • Overall response rate (ORR1) during first-line therapy, assessed by the investigator according to RECIST v.1.1 criteria [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival (PFS1), defined as time from randomization to first occurrence of disease progression or death, whichever occurs first, during first-line therapy [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01765582 on ClinicalTrials.gov Archive Site
  • Overall response rate during second-line therapy (ORR2), defined as proportion of patients with complete response or partial response during second-line therapy [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Progression-free survival during second-line therapy (PFS2), defined as time from reinduction of second-line therapy to disease progression or death from any cause, whichever occurs first [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Time to PFS2, defined as time from randomization to first occurrence of disease progression after reintroduction of second-line therapy [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Overall survival, defined as time from randomization to death of any cause [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Liver resection rate: Proportion of patients who undergo liver metastases resections [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Rates of conversion from unresectable to resectable disease (liver-limited and non-liver-limited disease) [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
STEAM: A Study of Sequential and Concurrent FOLFOXIRI/Avastin (Bevacizumab) Regimens Versus FOLFOX/Avastin in First-Line in Patients With Metastatic Colorectal Cancer
STEAM (SEQUENTIAL TRIPLET AND AVASTIN MAINTENANCE): FOLFOXIRI/BEVACIZUMAB REGIMENS (CONCURRENT AND SEQUENTIAL) VS. FOLFOX/BEVACIZUMAB IN FIRST-LINE METASTATIC COLORECTAL CANCER

This randomized, open-label, multicenter study will evaluate the efficacy and sa fety of FOLFOXIRI/Avastin (bevacizumab) regimens (concurrent and sequential) ver sus FOLFOX/Avastin in first-line in patients with metastatic colorectal cancer. Patients will be randomized to receive Avastin 5 mg/kg intravenously every 2 wee ks with either concurrent or sequential FOLFOXIRI or with FOLFOX for 4 to 6 mont hs of induction therapy, followed by maintenance therapy with Avastin plus eithe r leucovorin/5-fluorouracil or capecitabine until disease progression occurs. Af ter disease progression, patients will receive treatment with a fluoropyrimidine

-based chemotherapy plus Avastin.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Colorectal Cancer
  • Drug: bevacizumab [Avastin]
    5 mg/kg iv every 2 weeks, 4-6 months induction, followed by 5 mg/kg iv every 2 weeks or 7.5 mg/kg iv every 3 weeks maintenance therapy, and 2.5 mg/kg/week reinduction after disease progression
  • Drug: leucovorin
    iv every 2 weeks, 4-6 months induction followed by maintenance therapy
  • Drug: 5-fluorouracil
    iv every 2 weeks, 4-6 months induction followed by maintenance therapy
  • Drug: irinotecan
    iv every 2 weeks (Arm A) or iv 2 x 2 weeks cycles alternating months (Arm B), 4-6 months induction
  • Drug: oxaliplatin
    iv every 2 weeks (Arm C) or 2 x 2 week cycles alternating months (Arm B), 4-6 months induction
  • Drug: capecitabine [Xeloda]
    1000 or 850 mg/kg orally b.i.d. Day 1-14, repeated every 3 weeks, maintenance phase
  • Drug: fluoropyrimidine-based chemotherapy
    reinduction therapy after disease progression
  • Experimental: A: FOLFOXIRI + bevacizumab
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: leucovorin
    • Drug: 5-fluorouracil
    • Drug: irinotecan
    • Drug: capecitabine [Xeloda]
    • Drug: fluoropyrimidine-based chemotherapy
  • Experimental: B: sequential FOLFOXIRI + bevacizumab
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: leucovorin
    • Drug: 5-fluorouracil
    • Drug: irinotecan
    • Drug: oxaliplatin
    • Drug: capecitabine [Xeloda]
    • Drug: fluoropyrimidine-based chemotherapy
  • Experimental: C: FOLFOX + bevacizumab
    Interventions:
    • Drug: bevacizumab [Avastin]
    • Drug: leucovorin
    • Drug: 5-fluorouracil
    • Drug: oxaliplatin
    • Drug: capecitabine [Xeloda]
    • Drug: fluoropyrimidine-based chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
280
December 2017
December 2017   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adult patients, >/= 18 and </= 75 years of age
  • Histologically confirmed colorectal cancer with at least one measurable metastatic lesion by RECIST v1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Adequate hematological, renal and liver function
  • Patients with treated brain metastases are eligible for study participation; patients may not receive ongoing treatment with steroids at screening, anticonvulsants (at stable dose) are allowed
  • Females of childbearing potential and males must agree to use effective contraception as defined by protocol during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • Any prior treatment for metastatic colorectal cancer, except for use of palliative radiosensitizers
  • Adjuvant chemotherapy for colorectal cancer completed < 12 months prior to study consent
  • Sensory peripheral neuropathy >/= grade 2
  • Evidence of Gilbert's Syndrome or homozygosity for the UGT1A1*28 allele
  • Positive for HIV infection
  • Malignancies other than metastatic colorectal cancer within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, and ductal carcinoma in situ treated surgically with curative intent
  • Radiotherapy to any site for any reason within 28 days prior to randomization, except for palliative radiotherapy to bone lesions within 14 days prior to randomization
  • Clinically significant third-space fluid collections (e.g. ascites or pleural effusion) that cannot be controlled by drainage or other procedures prior to study entry
  • Treatment with any other investigational agent, or participation in an other investigational drug trial within 28 days prior to randomization
  • Pregnant or breastfeeding women
  • Any disease or condition or laboratory finding giving reasonable suspicion of disease or condition that contraindicates the use of bevacizumab or puts the patient at high risk for treatment-related complications
  • Inadequately controlled hypertension
  • Clinically significant (i.e. active) cardiovascular disease (e.g. cerebrovascular accident or myocardial infarction within 6 months prior to randomization), unstable angina, congestive heart failure (New York Heart Association Class >/= II) or serious cardiac arrhythmia that is uncontrolled by medication or may interfere with the administration of the study treatment
  • Known hypersensitivity to bevacizumab or any of its excipients or any other study drug
Both
18 Years to 75 Years
No
Contact: Reference Study ID Number: ML28442 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com
United States
 
NCT01765582
ML28442
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
July 2014

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