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

December 14, 2016 updated by: University of Miami

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)

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami Sylvester Comprehensive Cancer Center - Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • Taxotere
Drug: Oxaliplatin
Drug: Leucovorin
Other Names:
  • Folinic acid
  • Leucovorin calcium
Drug: Floxuridine
Other Names:
  • 5-FU
  • 5-fluorodeoxyuridine
  • FudR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2005

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

March 15, 2007

First Submitted That Met QC Criteria

March 15, 2007

First Posted (Estimate)

March 19, 2007

Study Record Updates

Last Update Posted (Estimate)

February 7, 2017

Last Update Submitted That Met QC Criteria

December 14, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20040005
  • SCCC-2003150 (Other Identifier: University of Miami Sylvester Comprehensive Cancer Center)
  • WIRB-20050983 (Other Identifier: Western Insitutional Review Board)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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