Back to results

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

Primary Purpose

Gastric Cancer

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Docetaxel

Floxuridine

Leucovorin

Oxaliplatin

About this trial

This is an interventional treatment trial for Gastric Cancer focused on measuring recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Miami Sylvester Comprehensive Cancer Center - Miami

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Arm Description

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.

Outcomes

Primary Outcome Measures

Number of Patients Achieving Clinical Response

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

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT00448682

First Posted

March 15, 2007

Last Updated

December 14, 2016

Sponsor

University of Miami

1. Study Identification

Unique Protocol Identification Number

NCT00448682

Brief Title

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

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)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Terminated

Study Start Date

June 2005 (undefined)

Primary Completion Date

December 2009 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Miami

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Docetaxel

Other Intervention Name(s)

Taxotere

Intervention Type

Drug

Intervention Name(s)

Floxuridine

Other Intervention Name(s)

5-fluorodeoxyuridine, 5-FU, FudR

Intervention Type

Drug

Intervention Name(s)

Leucovorin

Other Intervention Name(s)

Folinic acid, Leucovorin calcium

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin

Primary Outcome Measure Information:

Title

Number of Patients Achieving Clinical Response

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Overall Rate of Survival

Description

Time Frame

1 year

Title

Number of Participants Experiencing Adverse Events

Description

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

120 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bach Ardalan, MD

Organizational Affiliation

University of Miami Sylvester Comprehensive Cancer Center

Official's Role

Study Chair

Facility Information:

Facility Name

University of Miami Sylvester Comprehensive Cancer Center - Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33136

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs