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

NCT ID: NCT00448682

Last Updated: 2017-02-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-06-30
• Study Completion Date: 2010-03-31

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.

Conditions

Gastric Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Floxuridine

Intervention Type: DRUG

Leucovorin

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Interventions

Docetaxel

Intervention Type: DRUG

Floxuridine

Intervention Type: DRUG

Leucovorin

Intervention Type: DRUG

Oxaliplatin

Intervention Type: DRUG

Other Intervention Names

Taxotere; 5-fluorodeoxyuridine; 5-FU; FudR; Folinic acid; Leucovorin calcium

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bach Ardalan, MD

Role: STUDY_CHAIR

University of Miami Sylvester Comprehensive Cancer Center

Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

SCCC-2003150

Identifier Type: OTHER

Identifier Source: secondary_id

WIRB-20050983

Identifier Type: OTHER

Identifier Source: secondary_id

20040005

Identifier Type: -

Identifier Source: org_study_id