Status:
COMPLETED
Phase I/II Trial of Infusional Gemcitabine in Combination With Carboplatin in Chemonaive Non-small Cell Carcinoma
Lead Sponsor:
National University Hospital, Singapore
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Non Small Cell Lung Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Hypothesis - Infusional gemcitabine may give better intracellular pharmacologic activation and be more effective clinically in non-small cell lung cancer
Detailed Description
Objectives of study: 1. to compare the response rate of carboplatin and constant rate infusion gemcitabine to the response rate of gemcitabine given in the standard 30-minute infusion 2. to compare t...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
End Date :
February 1 2004
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT00212043
Start Date
July 1 2000
End Date
February 1 2004
Last Update
October 8 2009
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