Adjuvant Cisplatin and Docetaxel in Non Small Cell Lung Cancer

NCT00582634 | Completed Phase 2 DMC

• 4 other identifiers: H-2004-0248CO04503A534260SMPH/MEDICINE
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Non Small Cell Lung Cancer

Keywords

non small cell lung cancer; adjuvant; cisplatin; docetaxel

Outcome Measures

Primary Outcomes (3)

• Time to progression

  36 months

• Overall survival

  36 months

• Incidence of adverse events

  Baseline to 36 months

Secondary Outcomes (1)

• Correlate XPD and ERCC1 polymorphisms with time to progression and toxicities

  36 months

Study Arms (1)

Docetaxel followed by cisplatin

EXPERIMENTAL

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.

Drug: docetaxel and cisplatin

Interventions

docetaxel and cisplatin DRUG

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.

Also known as: Taxotere

Docetaxel followed by cisplatin

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin

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)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Anne Traynor, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: September 1, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: November 19, 2019

Record last verified: 2015-09

Locations

US (1)