Treatment of Lung Adenocarcinoma by Liposomal Cisplatin

Comparison of effectiveness of Liposomal Cisplatin combined with Paclitaxel versus Cisplatin combined with Paclitaxel in patients with adenocarcinoma and undifferentiated carcinoma of the lungs.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000046000

Enrollment

150

Registered

2010-01-18

Start date

2007-09-01

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

Liposomal Cisplatin has shown to be less toxic than Cisplatin. Dimished side effects such as nephrotoxicity and GI tract toxicity. The present study was to detect mainly the response rate between the two drugs combined with Paclitaxel.

Interventions

Liposomal Cisplatin 200 mg/m2 in 1 lt of dextrose for 8 hours infusion combined with Paclitaxel 135 mg/m2 infusion for 3 hours every 2 weeks for 9 cycles. Treatment was administered once every 2 weeks (on day 1 repeated on day 15th, then 29th and so on for 9 cycles).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 82 Years

Healthy volunteers

Inclusion criteria

Histologically or cytologically confirmed Non-Small-Cell lung cancer, treatment naive, bidimentionally measurable disease , performance status 0-2, expected survival = 12 weeks.

Exclusion criteria

Second primary malignancy, central nervous system metastasis.

Outcome results