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Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma

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ClinicalTrials.gov Identifier: NCT00212043
Recruitment Status : Completed
First Posted : September 21, 2005
Last Update Posted : October 8, 2009
Eli Lilly and Company
Information provided by:
National University Hospital, Singapore

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

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: carboplatin and gemcitabine Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma
Study Start Date : July 2000
Study Completion Date : February 2004

Resource links provided by the National Library of Medicine

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

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.

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): NCT00212043

Sponsors and Collaborators
National University Hospital, Singapore
Eli Lilly and Company
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Study Chair: Boon-Cher Goh National University Hospital, Singapore
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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ClinicalTrials.gov Identifier: NCT00212043    
Other Study ID Numbers: CTRG L08/99
First Posted: September 21, 2005    Key Record Dates
Last Update Posted: October 8, 2009
Last Verified: May 2008
Keywords provided by National University Hospital, Singapore:
randomised phase II trial gemcitabine and carboplatin
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs