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Weekly Docetaxel/Irinotecan for Non-Resectable Gastric Cancers After Cisplatin Plus 5-FU/Leucovorin (P-HDFL-DI)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Taiwan University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Far Eastern Memorial Hospital
Information provided by:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT00166881
First received: September 12, 2005
Last updated: August 26, 2008
Last verified: August 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Gastric Cancer
 Drug: Docetaxel-Irinotecan
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • Overall survival (OS) [ Time Frame: Five years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Objective response rates (CR, PR) [ Time Frame: Confirmed objective response after 4 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 40
Study Start Date: June 2000
Estimated Study Completion Date: March 2009
Estimated Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A, 2, III
Weekly Docetaxel-Irinotecan for Inoperable Gastric Cancers After P-HDFL
 Drug: Docetaxel-Irinotecan
Docetaxel-Irinotecan, weekly, days 1, 8, 15, repeated every 4 weeks
Other Names:
  • Docetaxel (taxotere)
  • Irinotecan (campto, CPT-11)

Detailed Description:
  1. 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
  2. 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
  3. To find out the optimal doses for docetaxel and irinotecan in a weekly dosing schedule for gastric cancer patients
  4. To evaluate the toxicities of weekly Docetaxel-Irinotecan regimen in inoperable gastric cancers
  Eligibility

Ages Eligible for Study:   16 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. CNS metastasis
  2. Patients receive concomitant anti-cancer C/T or R/T
  3. Patients who are pregnant and with an expected life expectancy less than 3 months
  4. Symptomatic heart disease, active infection, extensive liver disease, or liver cirrhosis
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00166881

Contacts
Contact: Kun-Huei Yeh, M.D., Ph.D. 886-2-23123456 ext 7514 khyeh@ntu.edu.tw
Contact: Ann-Lii Cheng, M.D., Ph.D. 886-2-23123456 ext 7251 andrew@ha.mc.ntu.edu.tw

Locations
Taiwan
Department of Oncology, National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Kun-Huei Yeh, M.D., Ph.D.     886-2-23123456 ext 67514     khyeh@ntu.edu.tw    
Contact: Ann-Lii Cheng, M.D., Ph.D.     886-2-23123456 ext 67251     andrew@ha.mc.ntu.edu.tw    
Principal Investigator: Kun-Huei Yeh, M.D., Ph.D.            
Sponsors and Collaborators
National Taiwan University Hospital
Far Eastern Memorial Hospital
Investigators
Study Chair: Ann-Lii Cheng, M.D.,Ph.D. Department of Oncology, National Taiwan University Hospital
  More Information

No publications provided

Responsible Party: Kun-Huei Yeh, Department of Oncology, National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT00166881     History of Changes
Other Study ID Numbers: 57M9
Study First Received: September 12, 2005
Last Updated: August 26, 2008
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Combination, Chemotherapy, Inoperable Gastric Cancer

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Irinotecan
Docetaxel
Cisplatin
Camptothecin
Leucovorin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013