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

NCT00448682 | Terminated Phase 2 Results DMC

• 3 other identifiers: 20040005SCCC-2003150WIRB-20050983
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• Overall Rate of Survival

  1 year

• Number of Participants Experiencing Adverse Events

  1 year

Study Arms (1)

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

EXPERIMENTAL

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.

Drug: Docetaxel; Drug: Floxuridine; Drug: Leucovorin; Drug: Oxaliplatin

Interventions

Docetaxel DRUG

Also known as: Taxotere

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Floxuridine DRUG

Also known as: 5-fluorodeoxyuridine, 5-FU, FudR

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Leucovorin DRUG

Also known as: Folinic acid, Leucovorin calcium

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Oxaliplatin DRUG

FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami Sylvester Comprehensive Cancer Center - Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Docetaxel; Floxuridine; Fluorouracil; Leucovorin; Oxaliplatin

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Deoxyuridine; Uridine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Uracil; Pyrimidinones; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Coordination Complexes

Limitations and Caveats

The study was terminated prematurely by the University of Miami Institutional Review Board. The results have not been analyzed.

Results Point of Contact

• Title: Bach Ardalan MD
• Organization: University of Miami Sylvester Comprehensive Cancer Center

bardalan@med.miami.edu

305-243-6608

Study Officials

• Bach Ardalan, MD

  University of Miami Sylvester Comprehensive Cancer Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2007
• First Posted: March 19, 2007
• Study Start: June 1, 2005
• Primary Completion: December 1, 2009
• Study Completion: March 1, 2010
• Last Updated: February 7, 2017
• Results First Posted: May 13, 2013

Record last verified: 2016-12

Locations

US (1)