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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)


Phase 2
18 Years
N/A
Not Enrolling
Both
Gastric Cancer

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Trial Information

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)


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Patients Achieving Clinical Response

Outcome Description:

Number of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Bach Ardalan, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Miami Sylvester Comprehensive Cancer Center

Authority:

United States: Food and Drug Administration

Study ID:

EPROST-20040005

NCT ID:

NCT00448682

Start Date:

June 2005

Completion Date:

March 2010

Related Keywords:

  • Gastric Cancer
  • recurrent gastric cancer
  • stage IV gastric cancer
  • adenocarcinoma of the stomach
  • Adenocarcinoma
  • Stomach Neoplasms

Name

Location

University of Miami Sylvester Comprehensive Cancer Center - Miami Miami, Florida  33136