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Taxol(Paclitaxel),UFT and Leucovorin in Patients With Advanced Gastric Cancer

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ClinicalTrials.gov Identifier: NCT00154778
Recruitment Status : Completed
First Posted : September 12, 2005
Last Update Posted : July 31, 2007
Sponsor:
Collaborators:
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Mackay Memorial Hospital
National Cheng-Kung University Hospital
National Health Research Institutes, Taiwan
Information provided by:
National Taiwan University Hospital

Brief Summary:
The purpose of this study is to evaluate the response rate of Paclitaxel combination chemotherapy with UFT and Leucovorin in patients with advanced gastric cancer.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Taxol, UFT,Leucovorin Phase 2

Detailed Description:
Since 1982,cancer has been the leading cause of death in Taiwan. In particular,gastric cancer is the fourth leading cause of death in male cancer patients and the sixth for female patients in 2000,accounting for an estimated 2,374 deaths. In recent years, the treatment of gastric cancer patients has gradually been improving due to advances in early diagnosis and surgical techniques. Although chemotherapy and radiation therapy have been used in either the adjuvant or palliative setting, their values are still limited due to their unacceptable toxicity or inadequate efficiency.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 55 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open,Multi-Center,Phase II Clinical Trial tO Evaluate Efficacy and Safety oF TAXOL(PACLITAXEL),UFT,and LEUCOVORIN in Patients With Advanced Gastric Cancer
Study Start Date : March 2003
Actual Study Completion Date : June 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arm Intervention/treatment
Experimental: A Drug: Taxol, UFT,Leucovorin



Primary Outcome Measures :
  1. To evaluate the response rate [ Time Frame: 2003~2004 ]

Secondary Outcome Measures :
  1. To determine time to progression and safety [ Time Frame: 2004~2005 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. At least 18 years old
  2. Patients with histologically confirmed gastric adenocarcinoma, defined as locally advanced unresectable or metastatic or recurrent disease
  3. Patients with at least one measurable lesion
  4. ECOG performance status of 0,1 or 2
  5. Patients with no prior chemotherapy and radiotherapy for metastatic disease (patients who have received and completed prior adjuvant chemotherapy at least 6 months prior to study enrollment may be enrolled into the study, prior taxane chemotherapy should be excluded)
  6. Patients with physiological functions (bone marrow, heart, liver, kidney, etc.) meeting the following criteria: WBC >4000/mm3, ANC >1500/mm3, PLT >100,000/mm3, Hb >9.0g/dL, ALT<3 times the ULN (<5 times the ULN for liver metastasis cases), Total bilirubin <1.5mg/dL, Creatinine <the upper limit of normal
  7. Accessible for treatment and follow-up
  8. Give written informed consent
  9. Women of child bearing potential must have a negative plasma or urine pregnancy test within 72 hours prior to start of the study medication

Exclusion Criteria:

  1. Patients who received surgery within 14 days prior to enrollment
  2. Patients with CNS metastasis
  3. History of hypersensitivity related to the administration of polyoxyethylated-castor-oil (cremophor EL)-containing preparation (e.g. cyclosporin,etc.) or hardened-castor-oil-containing preparation (e.g. vitamin preparation for injection,etc.)
  4. Patients with a history of severe hypersensitivity
  5. Active infectious symptoms
  6. Patients with active gastrointestinal bleeding, intestinal obstruction or other situation that dose not allow oral intake of medication
  7. Patients with ascites that adversely affects performance status
  8. Pre-existing CTC Grade 2 or greater neuropathy (motor or sensory)
  9. Pregnant or nursing females
  10. Patients who have participated in other clinical trials within 30 days prior to the first dose of the study drug

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00154778


Locations
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Taiwan
Department of Oncology, Nationa Taiwan University Hospital
Taipei, Taiwan, 100
Sponsors and Collaborators
National Taiwan University Hospital
Taipei Veterans General Hospital, Taiwan
Tri-Service General Hospital
Mackay Memorial Hospital
National Cheng-Kung University Hospital
National Health Research Institutes, Taiwan
Investigators
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Principal Investigator: Kun-Huei Yeh, M.D.,Ph.D. Department of Oncology, National Taiwan University Hospital

Additional Information:
Publications of Results:
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ClinicalTrials.gov Identifier: NCT00154778     History of Changes
Other Study ID Numbers: 910703
First Posted: September 12, 2005    Key Record Dates
Last Update Posted: July 31, 2007
Last Verified: July 2005
Keywords provided by National Taiwan University Hospital:
Combination,Chemotherapy,Advanced Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action