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Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-Small Cell Carcinoma
This study has been completed.
First Received: September 13, 2005   Last Updated: May 22, 2008   History of Changes
Sponsors and Collaborators: National University Hospital, Singapore
Eli Lilly and Company
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00212043
  Purpose

Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer


Condition Intervention Phase
Non Small Cell Lung Cancer
Drug: carboplatin and gemcitabine
Phase II

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Carboplatin Gemcitabine Gemcitabine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-Small Cell Carcinoma

Further study details as provided by National University Hospital, Singapore:

Estimated Enrollment: 74
Study Start Date: July 2000
Estimated Study Completion Date: February 2004
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • Histologically or cytologically confirmed NSCLC.

    • Stage IIIB unsuitable for radical radiation (eg. with cytologically proven malignant effusion) or stage IV disease as defined by the AJCC criteria (see appendix 1).
    • Karnofsky performance status 70% or higher (see appendix 2).
    • Presence of at least one bidimensionally or unidimensionally measurable, non-CNS, indicator lesion defined by radiologic study or physical examination.
    • No previous chemotherapy for advanced disease. Prior neoadjuvant or adjuvant chemotherapy, or chemotherapy given concurrently with radiotherapy for non-metastatic disease, is allowed if the last dose was given 6 months or more before study entry.
    • Patients with recurrent disease after primary surgery and/or radiotherapy will be eligible.
    • For patients with previous radiotherapy, the indicator lesion(s) must not be within previous radiation field. The last dose of radiotherapy should be at least 3 weeks prior to study entry. The total radiotherapy received should not be more than 30% of the bone marrow.
    • Screening laboratory criteria:

WBC count > 3500/microl Neutrophils > 2000/microl Platelet count > 100,000/microl Hemoglobin > 9 g/dl (transfusion allowed)

Serum creatinine < 133 micromol/l, or Creatinine clearance > 30 ml/min, based on the Cockcroft formula (see section 5.1.1)

Bilirubin < 1.5 x upper limit of normal ALT/AST < 2 x upper limit of normal if liver metastases are absent < 5 x upper limit of normal if liver metastases are present

  • Aged 18 years and above.
  • Life expectancy > 3 months.
  • Written informed consent.

Exclusion Criteria:

  • • Patients with only evaluable disease.

    • Active uncontrolled infection.
    • Pregnant or lactating women.
    • Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study.
    • Presence of any underlying medical conditions which in the investigators opinion would make the patient unsuitable for treatment.
    • Concomitant malignancies or previous malignancies other than NSCLC within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin, carcinoma-in-situ of the cervix, or stage A low grade prostate cancer.
    • Patients with CNS and/or leptomeningeal metastases; unless asymptomatic and not receiving corticosteriod therapy.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00212043

Sponsors and Collaborators
National University Hospital, Singapore
Eli Lilly and Company
Investigators
Study Chair: Boon-Cher Goh National University Hospital, Singapore
  More Information

Additional Information:
No publications provided by National University Hospital, Singapore

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Study ID Numbers: CTRG L08/99
Study First Received: September 13, 2005
Last Updated: May 22, 2008
ClinicalTrials.gov Identifier: NCT00212043     History of Changes
Health Authority: Singapore: Health Sciences Authority

Keywords provided by National University Hospital, Singapore:
randomised phase II trial gemcitabine and carboplatin

Study placed in the following topic categories:
Thoracic Neoplasms
Antimetabolites
Immunologic Factors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Carcinoma
Radiation-Sensitizing Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Non-small Cell Lung Cancer
Gemcitabine
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Carboplatin
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Carcinoma
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009