Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

University of Wisconsin (UW)

Status and phase: Completed; Phase 2

Conditions: Non Small Cell Lung Cancer

Treatments: Drug: docetaxel and cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT00582634

H-2004-0248 (Other Identifier)

SMPH/MEDICINE (Other Identifier)

CO04503 (Other Identifier)

A534260 (Other Identifier)

Details and patient eligibility

About

• 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

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

Docetaxel followed by cisplatin

Experimental group

Description:

Docetaxel (75mg/m2) given IV followed by cisplatin (75mg/m2) given IV on day 1 of a 21 day cycle. Both drugs will be administered intravenously over 1 hour each for 4 cycles.

Treatment:

Drug: docetaxel and cisplatin