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Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer

Sponsor
Fujian Cancer Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03137004
Collaborator
(none)
47
Enrollment
1
Location
1
Arm
16.3
Anticipated Duration (Months)
2.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A single-arm phase II study to evaluate the efficacy and safety of docetaxel plus S-1 (DS) as second-line treatment in patients with AGC.

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

For patients with advanced gastric cancer, combination chemotherapy has been shown to improve the quality of life and overall survival (OS) compared with best supportive care alone. Docetaxel is an active agent for treating patients with gastric cancer. S-1, an oral 5-FU prodrug, is active against AGC as a single agent or in combination with cisplatin in phase III trials. Therefore, a single-arm phase II study was conducted to investigate the efficacy and safety of biweekly docetaxel and S-1 (DS) combination therapy as second-line treatment in patients with previously treated advanced gastric cancer.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
47 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Single-arm Phase II Trial of Biweekly Docetaxel and S-1 Combination Therapy as Second-line Treatment for Advanced Gastric Cancer
Anticipated Study Start Date :
Jun 1, 2017
Anticipated Primary Completion Date :
Apr 10, 2018
Anticipated Study Completion Date :
Oct 10, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: biweekly DS

The biweekly DS regimen consisted of Docetaxel (50mg/m2) and S-1 (40mg/m2)

Drug: Docetaxel
Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.
Other Names:
  • Taxotere

    • Drug: S-1
    S-1 was administered orally at 40 mg/m2 twice daily on days 1-7 of each cycle. Patients with a body surface area of less than 1.25 m2 received 80 mg S-1 daily, those with a body surface area of 1.25 m2 or more but less than 1.5 m2 received 100 mg S-1 daily, and those with a body surface area of 1.5 m2 or more received 120 mg S-1 daily.
    Other Names:
  • TS-1

    		•

    Outcome Measures

    Primary Outcome Measures

    1. six-month overall survival [6 months]

    Secondary Outcome Measures

    1. Objective Response Rate (ORR) [6 months]

    2. Overall Survival (OS) [12 months]

    3. Progression-Free Survival (PFS) [12 months]

    4. Adverse Event（AE） [NCI CTC 4.03]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age: 18-75 years old;

    2. Histologically or cytologically confirmed unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma;

    3. The patient has experienced disease progression during treatment or within 4 months after the last dose of first-line therapy without taxanes for metastatic disease.

    4. Relapse within 6 months after adjuvant chemotherapy;

    5. ECOG (Eastern Cooperative Oncology Group)performance status 0-2;

    6. At least 1 measurable lesion should be present（RECIST1.1）

    7. Available Organ function: Neutrophils>2g/L, Hemoglobin>9g/L, Blood platelet >100g/L; Alanine aminotransferase(ALT） and Aspartate aminotransferase(AST)<1.5 ULN(upper limit of normal); Total bilirubin(TBIL)<1.0 ULN; Cr <1.0ULN

    8. Signed informed consent.

    9. Life expectancy ≥3 months;

    Exclusion Criteria:

    1. Previous treatment with taxanes (not including intraperitoneal use of taxanes);

    2. Known history of hypersensitivity to study drugs;

    3. Active CNS metastases not controllable with radiotherapy or corticosteroids;

    4. Pregnant or breast feeding women;

    5. Severe co-morbid illness and/or active infections;

    6. Active and uncontrollable bleeding from gastrointestinal tract

    7. Patients receiving a concomitant treatment with drugs interacting with S-1 such as flucytosine, phenytoin, or allopurinol;

    8. Other co-existing malignancies or malignancies diagnosed within the last 5 years(except cured cutaneum carcinoma or carcinoma in situs of cervix);

    9. Known HIV infecton.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Rongbo Lin Fuzhou Fujian China 350014

    Sponsors and Collaborators

    • Fujian Cancer Hospital

    Investigators

    • Study Chair: Rongbo Lin, MD, Fujian Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fujian Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT03137004
    Other Study ID Numbers:
    • FNF-005
    First Posted:
    May 2, 2017
    Last Update Posted:
    May 8, 2017
    Last Verified:
    May 1, 2017
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Additional relevant MeSH terms:
    Stomach Neoplasms
    Docetaxel

    Study Results

    No Results Posted as of May 8, 2017