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

Gastric Cancer Clinical Trial

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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00448682
• Other study ID #: UMIAMI-20040005
• Secondary ID: SCCC-2003150WIRB
• Status: Terminated
• Phase: Phase 2
• First received: March 15, 2007
• Last updated: July 25, 2014
• Start date: June 2005
• Est. completion date: March 2010

Study information

• Verified date: August 2013
• Source: University of Miami Sylvester Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 25
• Est. completion date: March 2010
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Gastric Cancer
• Stomach Neoplasms

Intervention

Drug:
• Docetaxel

• Floxuridine

• Leucovorin

• Oxaliplatin

Locations

Country	Name	City	State
United States	University of Miami Sylvester Comprehensive Cancer Center - Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami Sylvester Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	1 year	No
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.	1 year	No
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.	1 year	Yes