AzTrials
AzTrials

Gastric CancerPhase 2NCT00448682

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

A Phase 2 study testing Docetaxel, Floxuridine and Leucovorin in people with Gastric Cancer, run by University of Miami at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 120 years
Conditions the study is for
Gastric Cancer
What is being tested?
Docetaxel, Floxuridine and Leucovorin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteUnited States
Study dates
Jun 2005to Mar 2010
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Miami Sylvester Comprehensive Cancer Center - Miami

    Miami, Florida, 33136

Other trials in United States

About this study

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)

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.

Read the 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
Being tested
Docetaxel, Floxuridine, Leucovorin, Oxaliplatin
Keywords
recurrent gastric cancer, stage IV gastric cancer, adenocarcinoma of the stomach
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DocetaxelDrug

    Also called Taxotere

  • FloxuridineDrug

    Also called 5-fluorodeoxyuridine, 5-FU, FudR

  • LeucovorinDrug

    Also called Folinic acid, Leucovorin calcium

  • OxaliplatinDrug

Study groups in NCT00448682
Study groupRoleWhat they receive
FUdR + Leucovorin + Oxaliplatin + Docetaxel (Taxotere)ExperimentalTreatment 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.
Receives: Drug: Docetaxel; Drug: Floxuridine; Drug: Leucovorin; Drug: Oxaliplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (2)

  1. 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.

    Measured: 1 year

  2. 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.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2007 (estimated)
  2. Study startJun 2005
  3. Primary completionDec 2009
  4. Study completionMar 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
25 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00448682
Sponsor's protocol ID
20040005
Other IDs
SCCC-2003150, WIRB-20050983
Status last verified
Dec 2016
First submitted
15 Mar 2007
Last updated
7 Feb 2017
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docetaxel, Floxuridine and Leucovorin in people with Gastric Cancer, run by University of Miami at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Patients Achieving Clinical Response (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00448682.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in