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

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)

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00448682
Enrollment
25
Registered
2007-03-19
Start date
2005-06-30
Completion date
2010-03-31
Last updated
2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Cancer

Keywords

recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

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.

Interventions

DRUGDocetaxel
DRUGFloxuridine
DRUGLeucovorin
DRUGOxaliplatin

Sponsors

University of Miami
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Patients Achieving Clinical Response1 yearNumber of patients achieving complete response (CR) or partial response (PR) according to RECIST Criteria version 1.0.

Secondary

MeasureTime frameDescription
Overall Rate of Survival1 yearPatients 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 Events1 yearNumber of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.

Countries

United States

Participant flow

Participants by arm

ArmCount
FUdR + Leucovorin + Oxaliplatin + Docetaxel
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.
25
Total25

Baseline characteristics

CharacteristicFUdR + Leucovorin + Oxaliplatin + Docetaxel
Age, Continuous62 years
Gender
Female
7 Participants
Gender
Male
18 Participants
Region of Enrollment
United States
25 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Number of Patients Achieving Clinical Response

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

Time frame: 1 year

Population: The study data has not been analyzed.

Secondary

Number of Participants Experiencing Adverse Events

Number of participants experiencing adverse events within 1 year of receiving combination therapy of FUDR + Leucovorin + Oxaliplatin + Docetaxel for metastatic gastric adenocarcinoma.

Time frame: 1 year

Population: The study data has not been analyzed.

Secondary

Overall Rate of Survival

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.

Time frame: 1 year

Population: The study data has not been analyzed.

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026