NCT00980382

Brief Summary

This study is an open-label, single center, nonrandomized study, consisting of a dose-escalating phase I study in advanced solid cancer and a subsequent phase II study in metastatic gastric cancer. In phase I study, we aim to determine the MTD and the recommended dose of S-1 combined with docetaxel given every 3 weeks. Dose level and escalating schedule are followings

  • S-1(level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14)
  • Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) mixed in d5w 200 ml iv over 60 min: Days 1, 8with dexamethasone 8 mg po q 12hr for 3 days (total 6 doses: D0-2)and parenteral pheniramine maleate 1 ample (45.5mg) before docetaxel

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
85

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Sep 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

September 18, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2009

Completed
Last Updated

September 21, 2009

Status Verified

September 1, 2009

Enrollment Period

2.9 years

First QC Date

September 18, 2009

Last Update Submit

September 18, 2009

Conditions

Stomach Neoplasms

Keywords

Stomach Neoplasmsphase I/IICombination chemotherapyS-1Docetaxel

Outcome Measures

Primary Outcomes (1)

  • *phase I study:the maximum tolerated doses (MTD)of S-1 and docetaxel,recommended dose for subsequent phase II study *phase II study: evaluation of efficacy and toxicities of this new combination regimen in metastatic

    During chemotherapy

Secondary Outcomes (1)

  • To investigate the time to progression and overall survival

    During study period

Interventions

S-1, DocetaxelDRUG

* Phase I study * S-1 (level 0, 1/2, 3/4, 5: 60, 70, 80, 90 mg/m2/day) q 12 hours po Days 1-14 * Docetaxel (level 0/1,2/3, 4/5: 25, 30, 35 mg/m2) iv : Days 1, 8 * Phase II study * S-1 (80mg/m2/day) q 12 hours po Days 1-14 * Docetaxel (35 mg/m2) iv : Days 1, 8

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In phase I:histologically or cytologically confirmed advanced solid Cancer In phase II:histologically or cytologically confirmed metastatic gastric adenocarcinoma
  • Age: over 18 years
  • No prior chemotherapy or radiotherapy (including any adjuvant hemotherapy) in phase II portion Previous chemotherapy up to two regimens (including adjuvant chemotherapy) is allowed in phase I portion; patients are required to have discontinued chemotherapy, immunotherapy, and radiotherapy for at least 4 weeks before entry into phase I portion
  • Disease status must be that of measurable disease defined as: Lesions that can be accurately measured in at least one dimension \>10 mm with spiral CTscan and palpable LN (including supraclavicular LN) in physical examination.
  • Performance status: ECOG 0-2
  • Adequate major organ function including the following Hematopoietic function: WBC\>4,000/mm3 or ANC\> 2,000/mm3, Platelet count ³ 100,000/mm3Hepatic function: Bilirubin UNL (Upper normal limit), AST/ALT levels 2.5X UNL Renal function: Creatinine UNL
  • Patients should sign an informed consent

You may not qualify if:

  • Inadequate cardiovascular function: New York Heart Association class III or IV heart disease Active angina or myocardial infarction within the past 6 monthsHistory of significant ventricular arrhythmia requiring medication with antiarrhythmics or significantconduction system abnormality
  • Other malignancy within the past 3 years except nonmelanomatous skin cancer or carcinoma in situ of the cervix
  • Pregnant or nursing women
  • Serious concurrent infection or nonmalignant illness that is uncontrolled or whose control may be jeopardized by complications of study therapy
  • Psychiatric disorder that would preclude compliance
  • Patients receiving a concomitant treatment with drugs interacting with S-1 or docetaxel: flucytosine, phenitoin, warfarin et al.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

S 1 (combination)Docetaxel

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Officials

  • Sook Ryun Park, M.D

    National Cancer Center, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 18, 2009

First Posted

September 21, 2009

Study Start

September 1, 2004

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

September 21, 2009

Record last verified: 2009-09

Locations

KR(1)