A phase III randomized study with Paclitaxel (Taxol) and Gemcitabine or Vinorelbine in patients with stage IIIBw - IV non-operable non-small cell lung cancer (NSCLC), performance status (PS) 0,1.

The comparative effect of combination chemotherapy with Paclitaxel (Taxol) and Gemcitabine vs Taxol and Vinorelbine on survival in non-operable non-small cell lung cancer stage IIIBw and IV, PS : 0, 1. A Phase III randomized study.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000946213

Enrollment

441

Registered

2009-11-04

Start date

2004-06-29

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a prospective randomized phase III study comparing Paclitaxel and Gemcitabine with Paclitaxel and Vinorelbine in the treatment of patients with advanced non – operable non-small cell lung cancer (NSCLC). Patients are randomized into two groups: Group A receive Gemcitabine on days 1 and 8 and Paclitaxel on day 1, every 3 weeks. Group B receive: Paclitaxel and Vinorelbine on days 1, 8, 15 every 4 weeks. Both regimens will be given for 4 cycles. The following parameters will be evaluated: Survival, Time to progression, Response rates, Toxicity

Interventions

GROUP B Days 1, 8, 15 Taxol: 80mg/m2 in Normal Saline (N/S) 0.9% in 3h infusion followed premedication. Vinorelbine : 22.5mg/m2 in 10 minute infusion followed by vein washing with normal saline. Vinorelbine will be given first followed by Taxol. Treatment will be repeated every 4 weeks for a total of 4 cycles No growth factor routinely will be given and antiemetic h² blockers (H2-receptor antagonists) will be used accordingly .

Study design

Allocation

Randomised controlled trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Histologically proven inoperable or recurrent or metastatic NSCLC stage IIIBw and IV. Biopsy, fine needle aspiration or sputum cytology will be used to obtain the samples. Performance status 0, 1 of the Eastern Cooperative Oncology Group (ECOG) scale . Measurable disease outside prior radiotherapy ports required , unless subsequent progression is documented . Stable brain metastases . Prior surgery or radiotherapy is allowed . Age > 18 years . Life expectancy at least 12 weeks. White Blood Cells (WBC) > 4.000/ml or platelets > 100.000/ml, Bilirubin < 1.2 mg/dl, gamma-glutamyltranspeptidase, alkaline phosphatase (ALP) normal, serum creatinine < 1.4 mg/dl and creatinine clearance > 60 ml/min. Informed consent has to be signed.

Exclusion criteria

Past or current history of neoplasm, except for Basal cell carcinoma of the skin or carcinoma in situ of the cervix. Previous treatment with chemotherapy for recurrent or metastatic disease. History of atrial or ventricular arrhythmias, congestive heart failure even if medically controlled. Documented myocardial infarction. Pre – existing motor or sensory neurotoxicity grade >2 according to World Health Organisation (WHO) scale (intolerable paresthesias and/or marked motor loss , or worse). Active infection or other serious underlying medical condition which would impair the ability of the patient to receive protocol treatment .

Outcome results