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Completed

NCT Number: NCT00980382

A Phase I/II Study of S-1 and Weekly Docetaxel for Metastatic Gastric Carcinoma

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

National Cancer Center Korea

Goyang-si, Gyeonggi-do, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

S-1, Docetaxel

Drug
  • 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

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

    Time frame: During chemotherapy

Secondary outcomes

  1. To investigate the time to progression and overall survival

    Time frame: During study period

Sponsors and collaborators

Lead sponsor

National Cancer Center, Korea

Other Gov

Registry information

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 21, 2009
Registry last updated
Sep 21, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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