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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National University Hospital, Singapore
• Collaborator: Eli Lilly and Company
• Treatments: Carboplatin; Gemcitabine

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.