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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.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00212043
First Posted: September 21, 2005
Last Update Posted: October 8, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by:
National University Hospital, Singapore
  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 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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
Investigators
Study Chair: Boon-Cher Goh National University Hospital, Singapore
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00212043     History of Changes
Other Study ID Numbers: CTRG L08/99
First Submitted: September 13, 2005
First Posted: September 21, 2005
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:
Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Carboplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs