Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

Phase II Study of Adjuvant Cisplatin and Docetaxel in Non-small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00582634

Enrollment

Registered

2007-12-28

Start date

2004-09-30

Completion date

2007-12-31

Last updated

2019-11-19

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

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer, adjuvant, cisplatin, docetaxel

Brief summary

* To determine if docetaxel and cisplatin can be administered in a dose intense manner in the adjuvant setting in resected non-small cell lung cancer * To evaluate the time to progression and overall survival * To evaluate toxicities of this chemotherapy combination in the adjuvant setting * To correlate XPD and ERCC1 polymorphisms with time to progression and toxicities in patients treated with this regimen

Interventions

DRUGdocetaxel and cisplatin

Docetaxel (75mg/m2) followed by cisplatin (75mg/m2) on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for4 cycles.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stage IB to IIIA non-small cell lung cancer completely resected within 4 to 8 weeks of initiating treatment on study * Performance Status ECOG 0 or 1 * Peripheral neuropathy: \< grade 1 * Adequate blood cell counts * Adequate liver and hepatic function * Women of childbearing potential must have a negative pregnancy test. * Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter

Exclusion criteria

* Patients with a history of severe hypersensitivity reaction to Docetaxel® or other drugs formulated with polysorbate 80. * Women who are breast-feeding. * Coexistent second malignancy or history of prior malignancy within previous 5 years (excluding basal or squamous cell carcinoma of the skin that has been treated curatively) * Uncontrolled cardiac disease or uncontrolled hypertension

Design outcomes

Primary

Measure	Time frame
Time to progression	36 months
Overall survival	36 months
Incidence of adverse events	Baseline to 36 months

Secondary

Measure	Time frame
Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities	36 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026