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Trial record 27 of 54 for:    colon cancer | ( Map: Mississippi, United States )

A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer

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ClinicalTrials.gov Identifier: NCT00192075
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : December 23, 2009
Last Update Posted : February 7, 2011
Sponsor:
Information provided by:
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE September 12, 2005
First Posted Date  ICMJE September 19, 2005
Results First Submitted Date  ICMJE October 30, 2008
Results First Posted Date  ICMJE December 23, 2009
Last Update Posted Date February 7, 2011
Study Start Date  ICMJE June 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST) [ Time Frame: baseline to measured progressive disease (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) ]
Response using Response Evaluation Criteria In Solid Tumors (RECIST) criteria. Complete Response=disappearance of all target lesions; Partial Response=30% decrease in sum of longest diameter of target lesions; Progressive Disease=20% increase in sum of longest diameter of target lesions; Stable Disease=small changes that do not meet above criteria.
Original Primary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
Tumor Response by Response Evaluation Criteria In Solid Tumors (RECIST)
Change History Complete list of historical versions of study NCT00192075 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 4, 2011)
  • Time to Progressive Disease [ Time Frame: randomization to the date of first documented disease progression or death due to disease under study, whichever comes first (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) ]
    Defined as the time from study enrollment to the first date of disease progression. Time to disease progression was censored at the date of death if death was due to other cause.
  • Progression-Free Survival [ Time Frame: randomization to the first date of progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) ]
    Defined as the time from randomization to the first observation of disease progression, or death due to any cause.
  • Overall Survival [ Time Frame: randomization to the date of death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) ]
    Overall survival is the duration from enrollment to death. For patients who are alive, overall survival is censored at the last contact.
  • Duration of Response [ Time Frame: date of first response until the first date of documented progression or death from any cause (every 7-8 weeks for 2 cycles, monthly for 3 months, every other month for 6 months, then every 3 months up to 4.4 years) ]
    The duration of a complete response (CR) or partial response (PR) was defined as the time from first objective status assessment of CR or PR to the first time of progression or death as a result of any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2005)
  • Time to Treatment Failure from date of randomization to the date of early discontinuation, progression of diseaease, or death due to any cause.
  • Progression-free survival from the date of randomization to the first date of progression or death from any cause.
  • Overall survival from the date of randomization to the date of death from any cause.
  • Toxicity by CTCAE grading.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Trial of Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid Versus Avastin + Oxaliplatin + 5FU/Folinic Acid in Metastatic Colorectal Cancer
Official Title  ICMJE A Multicenter, Randomized Phase II Trial of Avastin Plus Gemcitabine Plus 5FU/Folinic Acid (A + FFG) vs. Avastin Plus Oxaliplatin Plus 5FU/Folinic Acid (A + FOLFOX 4) as Therapy for Patients With Metastatic Colorectal Cancer
Brief Summary The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The amount and type of side effects/toxicities of each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is a current standard of care.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: Gemcitabine
    900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression.
    Other Name: Gemzar
  • Drug: avastin
    5 milligrams per kilogram (mg/kg)
  • Drug: 5FU/folinic acid

    Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).

    Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).

    5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).

  • Drug: oxaliplatin
    85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.
Study Arms  ICMJE
  • Experimental: A+FFG
    Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid
    Interventions:
    • Drug: Gemcitabine
    • Drug: avastin
    • Drug: 5FU/folinic acid
  • Active Comparator: A+FOLFOX 4
    Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid
    Interventions:
    • Drug: avastin
    • Drug: 5FU/folinic acid
    • Drug: oxaliplatin
Publications * Madajewicz S, Waterhouse DM, Ritch PS, Khan MQ, Higby DJ, Leichman CG, Malik SK, Hentschel P, Gill JF, Zhao L, Nicol SJ. Multicenter, randomized phase II trial of bevacizumab plus folinic acid, fluorouracil, gemcitabine (FFG) versus bevacizumab plus folinic acid, fluorouracil, oxaliplatin (FOLFOX4) as first-line therapy for patients with advanced colorectal cancer. Invest New Drugs. 2012 Apr;30(2):772-8. doi: 10.1007/s10637-010-9598-9. Epub 2010 Dec 1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2009)
84
Original Enrollment  ICMJE
 (submitted: September 13, 2005)
190
Actual Study Completion Date  ICMJE November 2007
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients must have a histological or cytological diagnosis of the colon or rectum with Stage III unresectable or Stage IV disease.
  • Urinalysis or Urine dipstick for proteinuria of less than 1+ (i.e. either 0 or trace). If urine dipstick is greater than 1+, the 24 hour urine protein must demonstrate less than 500 mg of protein in 24 hours to allow participation.
  • No prior chemotherapy, immunotherapy, or hormonal treatment for metastatic disease is acceptable. However, one prior neo-adjuvant or adjuvant treatment is acceptable, including Capecitabine, Camptothecin-11 (CPT-11), 5 Fluorouracil/Leucovorin (5FU/LV) or Radiation containing regimens, (but no Oxaliplatin), and only if progression > 6 months since last adjuvant treatment.
  • Prior radiation therapy, including radiation to the whole pelvis, is allowed (Cristy and Eckerman 1987) and patients must have recovered from the acute toxic effects of the treatment prior to study enrollment. Prior palliative radiation therapy given to a non-measurable diagnostic site is acceptable if given > 4 weeks prior to treatment or if other non-irradiated measurable disease is present.
  • No known central nervous system (CNS) metastasis.

Exclusion Criteria:

  • Histology other than adenocarcinoma
  • Tumors that demonstrate free perforation as manifested by free air or free fluid in the abdomen. Patients with walled-off perforation are eligible.
  • Gastroduodenal ulcer determined as active by endoscopy.
  • Invasive procedures defined as follows; major surgical procedures, open biopsy, or significant traumatic injury within 28 days prior to randomization, anticipation of need for major surgical procedure during the course of study, core biopsy or other minor procedure within 7 days prior to registration.
  • Following cardiac condition; New York Heart Association (NYHA) Class III or IV, myocardial infarction (MI) within 6 months, unstable angina within 6 months and current symptomatic arrhythmia.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries Puerto Rico
 
Administrative Information
NCT Number  ICMJE NCT00192075
Other Study ID Numbers  ICMJE 8142
B9E-US-S337 ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Chief Medical Officer, Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date November 2009

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