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

NCT00212043 | Completed Phase 2

• 1 other identifier: CTRG L08/99
• Study Type: interventional
• Target: 74
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Non Small Cell Lung Cancer

Keywords

randomised phase II trial gemcitabine and carboplatin

Interventions

carboplatin and gemcitabine DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Eli Lilly and Company: collaborator

Related Publications (1)

• Tham LS, Wang LZ, Soo RA, Lee HS, Lee SC, Goh BC, Holford NH. Does saturable formation of gemcitabine triphosphate occur in patients? Cancer Chemother Pharmacol. 2008 Dec;63(1):55-64. doi: 10.1007/s00280-008-0707-9. Epub 2008 Feb 28.

  PMID: 18305939 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Boon-Cher Goh

  National University Hospital, Singapore

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 21, 2005
• Study Start: July 1, 2000
• Study Completion: February 1, 2004
• Last Updated: October 8, 2009

Record last verified: 2008-05