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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

Study Description
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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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxel Drug: Floxuridine Drug: Leucovorin Drug: Oxaliplatin Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : June 2005
Actual Primary Completion Date : December 2009
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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Arm Intervention/treatment
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.

 Drug: Docetaxel
Other Name: Taxotere

Drug: Floxuridine
Other Names:
  • 5-fluorodeoxyuridine
  • 5-FU
  • FudR

Drug: Leucovorin
Other Names:
  • Folinic acid
  • Leucovorin calcium

Drug: Oxaliplatin


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00448682


Locations
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United States, Florida
University of Miami Sylvester Comprehensive Cancer Center - Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
Investigators
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Study Chair: Bach Ardalan, MD University of Miami Sylvester Comprehensive Cancer Center
More Information
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Responsible Party: University of Miami
ClinicalTrials.gov Identifier: NCT00448682     History of Changes
Other Study ID Numbers: 20040005
SCCC-2003150 ( Other Identifier: University of Miami Sylvester Comprehensive Cancer Center )
WIRB-20050983 ( Other Identifier: Western Insitutional Review Board )
First Posted: March 19, 2007    Key Record Dates
Results First Posted: May 13, 2013
Last Update Posted: February 7, 2017
Last Verified: December 2016
Keywords provided by University of Miami:
recurrent gastric cancer
stage IV gastric cancer
adenocarcinoma of the stomach
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
 Oxaliplatin
Floxuridine
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites