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Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery

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ClinicalTrials.gov Identifier: NCT00448682
Recruitment Status : Terminated
First Posted : March 19, 2007
Results First Posted : May 13, 2013
Last Update Posted : February 7, 2017
Sponsor:
Information provided by (Responsible Party):
University of Miami

Tracking Information
First Submitted Date  ICMJE March 15, 2007
First Posted Date  ICMJE March 19, 2007
Results First Submitted Date  ICMJE February 21, 2013
Results First Posted Date  ICMJE May 13, 2013
Last Update Posted Date February 7, 2017
Study Start Date  ICMJE June 2005
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
Number of Patients Achieving Clinical Response [ Time Frame: 1 year ]
Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.
Original Primary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
  • Overall clinical response rate (complete response and partial response)
  • Efficacy
Change History Complete list of historical versions of study NCT00448682 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 29, 2013)
  • Overall Rate of Survival [ Time Frame: 1 year ]
    Patients will be followed for overall survival from date of enrollment to date of death or last contact. The extent of follow up will be described by the range and median for deceased patients and for those alive at last follow up. We will estimate the 1 year survival rates by the Kaplan-Meier method.
  • Number of Participants Experiencing Adverse Events [ Time Frame: 1 year ]
    Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.
Original Secondary Outcome Measures  ICMJE
 (submitted: March 15, 2007)
  • Safety
  • Overall survival
  • Time to progression
  • 6-month survival
  • 1-year survival
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Combination Chemotherapy as First-Line Therapy in Treating Patients With Stage IV Gastric Cancer That Cannot Be Removed By Surgery
Official Title  ICMJE A Phase II Study of Weekly 24-hour Infusion 5-fluoro-deoxyuridine (FUdR)/Leucovorin With Oxaliplatin and Docetaxel (Taxotere) as First-line Treatment in Patients With Metastatic Gastric Adenocarcinoma (IIT# 14065)
Brief Summary

RATIONALE: Drugs used in chemotherapy, such as floxuridine, leucovorin, oxaliplatin, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well combination chemotherapy works as first-line therapy in treating patients with stage IV gastric cancer that cannot be removed by surgery.

Detailed Description

OBJECTIVES:

Primary

  • Determine the overall response rate in patients with unresectable stage IV gastric adenocarcinoma treated with floxuridine, leucovorin calcium, oxaliplatin, and docetaxel as first-line treatment.

Secondary

  • Determine the feasibility of this regimen in managing patients with unresectable stage IV gastric adenocarcinoma who have not received prior chemotherapy for metastatic disease.
  • Determine disease-free survival of patients treated with this regimen.
  • Evaluate overall survival of patients treated with this regimen.
  • Assess the safety and toxicity of this regimen in these patients.

OUTLINE: Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and docetaxel IV over 30 minutes, floxuridine IV over 24 hours, and leucovorin calcium IV over 24 hours on days 1, 8, and 15. Treatment repeats every 4 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 26 patients will be accrued for this study.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Gastric Cancer
Intervention  ICMJE
  • Drug: Docetaxel
    Other Name: Taxotere
  • Drug: Floxuridine
    Other Names:
    • 5-fluorodeoxyuridine
    • 5-FU
    • FudR
  • Drug: Leucovorin
    Other Names:
    • Folinic acid
    • Leucovorin calcium
  • Drug: Oxaliplatin
Study Arms  ICMJE Experimental: FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:

Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.

Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).

There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles.

Interventions:
  • Drug: Docetaxel
  • Drug: Floxuridine
  • Drug: Leucovorin
  • Drug: Oxaliplatin
Publications * Not Provided

*   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 Terminated
Actual Enrollment  ICMJE
 (submitted: January 22, 2013)
25
Original Enrollment  ICMJE
 (submitted: March 15, 2007)
26
Actual Study Completion Date  ICMJE March 2010
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed gastric adenocarcinoma meeting the following criteria:

    • Stage IV disease OR stage III disease that was re-staged as metastatic disease at time of surgery
    • Unresectable disease
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan
  • No CNS metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status (PS) 0-1 OR Karnofsky PS 70-100%
  • Absolute neutrophil count ≥ 1,500/mm^3
  • Hemoglobin ≥ 8.0 g/dL
  • Platelet count ≥ 100,000/mm^3
  • Bilirubin normal
  • Creatinine ≤ 1.5 mg/dL
  • Alkaline phosphatase (AP), AST, and ALT must meet 1 of the following criteria:

    • AP normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
    • AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
    • AP ≤ 5 times ULN AND AST and ALT normal
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after completion of study therapy
  • No peripheral neuropathy > grade 1
  • No history of severe hypersensitivity reaction to platinum agents (e.g., cisplatin or carboplatin), fluoropyrimidines, or drugs formulated with polysorbate 80
  • No concurrent serious illness that would preclude study treatment or compliance
  • No active infections requiring intravenous antibiotic therapy
  • No other malignancy within the past 5 years except for cervical carcinoma in situ, breast ductal carcinoma in situ, colonic polyp, or squamous cell or basal cell carcinoma of the skin
  • No clinically significant uncontrolled cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias) or myocardial infarction within the past 12 months

PRIOR CONCURRENT THERAPY:

  • No prior radiotherapy for metastatic gastric carcinoma
  • No prior chemotherapy for metastatic gastric carcinoma

    • Prior neoadjuvant or adjuvant chemotherapy and/or radiotherapy allowed if completed therapy at least 12 months before study enrollment

      • Chemotherapy may have included taxane, platinum, or fluoropyrimidine-based regimen
  • At least 2 months since prior surgery and recovered
  • No other concurrent investigational agents
  • No other concurrent anticancer agents or therapies
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 120 Years   (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  
 
Administrative Information
NCT Number  ICMJE NCT00448682
Other Study ID Numbers  ICMJE 20040005
SCCC-2003150 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20050983 ( Other Identifier: Western Insitutional Review Board )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Miami
Study Sponsor  ICMJE University of Miami
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Bach Ardalan, MD University of Miami Sylvester Comprehensive Cancer Center
PRS Account University of Miami
Verification Date December 2016

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