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Completed

NCT Number: NCT00166881

Weekly Docetaxel/Irinotecan for Non-resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin

In this study, the investigators will use P-HDFL, a regimen with high tumor remission rate (~ 60-70%) and with only modest treatment-associated toxicities, as induction chemotherapy for patients with non-resectable gastric cancer. For those patients who have achieved complete response (CR) or partial response (PR), DI will be used to "consolidate" the remission. For those patients who fail to achieve remission by P-HDFL, DI will be used as salvage chemotherapy. The efficacy and toxicities of DI in these two settings will be evaluated in this prospective study.

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Key information

Conditions

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

Age range

16 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Oncology, National Taiwan University Hospital

Taipei, 100, Taiwan

About this study

  • To evaluate if weekly Docetaxel-Irinotecan,a potentially non-cross-resistant regimen,can prolong the overall survival (OS) or the duration of remission in those patients who have achieved CR or PR by P-HDFL regimen
  • To evaluate the efficacy of weekly Docetaxel-Irinotecan combination as salvage regimen for those patients who have either failed to achieve remission or have recurred from P-HDFL chemotherapy
  • To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
  • To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically or cytologically confirmed gastric adenocarcinoma
  • Measurable or evaluable disease
  • No previous C/T
  • Age 16 ~ 75 years
  • Karnofsky Performance Status of 60%
  • 4 weeks after R/T
  • Adjuvant C/T: the last dosing of C/T 6 months before enrollment
  • WBC >= 4,000, platelets >= 100K, Creatinine <= 1.5mg/dl and proteinuria <1+, normal serum bil, transaminase <= 3.5x ULN, TG > 70mg/dl

Exclusion criteria

  • CNS metastasis
  • Patients receive concomitant anti-cancer C/T or R/T
  • Patients who are pregnant and with an expected life expectancy less than 3 months
  • Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis

Treatment and study plan

Docetaxel-Irinotecan

Drug

Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks

Other names: Docetaxel (taxotere), Irinotecan (campto, CPT-11)

Primary outcomes

  1. Overall survival (OS)

    Time frame: Five years

Secondary outcomes

  1. Objective response rates (CR, PR)

    Time frame: Confirmed objective response after 4 weeks

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • Far Eastern Memorial Hospital

Registry information

Official study title

Phase II Trial of Consolidation or Salvage Chemotherapy by Using Weekly Docetaxel/Irinotecan After Cisplatin Plus Weekly 24-Hour Infusion of High-dose 5-Fluorouracil/Leucovorin for Non-resectable Gastric Cancers

Acronym: P-HDFL-DI

Important dates

Study start
2000
Primary completion
2010
Study completion
2011
First posted
Sep 14, 2005
Registry last updated
Jul 8, 2013

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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