Trial record 1 of 1 for:    NCT01765582
Previous Study | Return to List | Next Study

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 October 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: October 20, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Drug: 5-fluorouracil
Drug: bevacizumab [Avastin]
Drug: capecitabine [Xeloda]
Drug: fluoropyrimidine-based chemotherapy
Drug: irinotecan
Drug: leucovorin
Drug: oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: STEAM (SEQUENTIAL TRIPLET AND AVASTIN MAINTENANCE): FOLFOXIRI/BEVACIZUMAB REGIMENS (CONCURRENT AND SEQUENTIAL) VS. FOLFOX/BEVACIZUMAB IN FIRST-LINE METASTATIC COLORECTAL CANCER

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 280
Study Start Date: January 2013
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: FOLFOXIRI + bevacizumab Drug: 5-fluorouracil
iv every 2 weeks, 4-6 months induction followed by maintenance therapy
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: 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
Drug: irinotecan
iv every 2 weeks (Arm A) or iv 2 x 2 weeks cycles alternating months (Arm B), 4-6 months induction
Drug: leucovorin
iv every 2 weeks, 4-6 months induction followed by maintenance therapy
Experimental: B: sequential FOLFOXIRI + bevacizumab Drug: 5-fluorouracil
iv every 2 weeks, 4-6 months induction followed by maintenance therapy
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: 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
Drug: irinotecan
iv every 2 weeks (Arm A) or iv 2 x 2 weeks cycles alternating months (Arm B), 4-6 months induction
Drug: leucovorin
iv every 2 weeks, 4-6 months induction followed by maintenance therapy
Drug: oxaliplatin
iv every 2 weeks (Arm C) or 2 x 2 week cycles alternating months (Arm B), 4-6 months induction
Experimental: C: FOLFOX + bevacizumab Drug: 5-fluorouracil
iv every 2 weeks, 4-6 months induction followed by maintenance therapy
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: 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
Drug: leucovorin
iv every 2 weeks, 4-6 months induction followed by maintenance therapy
Drug: oxaliplatin
iv every 2 weeks (Arm C) or 2 x 2 week cycles alternating months (Arm B), 4-6 months induction

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01765582

Contacts
Contact: Reference Study ID Number: ML28442 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 44 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01765582     History of Changes
Other Study ID Numbers: ML28442
Study First Received: January 9, 2013
Last Updated: October 20, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases
Bevacizumab
Capecitabine
Fluorouracil
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antimetabolites
Antimetabolites, Antineoplastic
Antineoplastic Agents
Growth Inhibitors
Growth Substances
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014