Trial of Neoadjuvant Docetaxel and Cisplatin for Resectable Non-Small Cell Lung Cancer

NCT00232206 | Terminated Phase 2

• 2 other identifiers: PPMC-EACRI-IRB-05-032IIT #12207
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to assess the response rate of treatment with two cycles of cisplatin and docetaxel chemotherapy prior to surgery (neoadjuvant) for early stage non-small cell lung cancer (NSCLC). Secondary objectives of this study include assessment of radiographic response rate by computed tomography (CT) scanning, overall survival, time to progression, rate of complete surgical removal, and adverse reactions. In addition, this study will test whether positron emission tomography (PET) imaging can predict a tumor response. Patients who have a response to chemotherapy may receive 2 additional cycles after recovering from surgery.

Conditions

Non-small-Cell Lung Carcinoma

Keywords

NSCLC; Lung; Cancer; Metastatic; Neoadjuvant; Stage IB Non-Small Cell Lung Cancer (NSCLC); IIA Non-Small Cell Lung Cancer (NSCLC); IIB Non-Small Cell Lung Cancer (NSCLC); Some IIIA Non-Small Cell Lung Cancer (NSCLC)

Outcome Measures

Primary Outcomes (1)

• Primary objective: To assess the pathologic complete and partial response rate to neoadjuvant treatment with two cycles of cisplatin and docetaxel chemotherapy prior to resection of early stage NSCLC

Secondary Outcomes (2)

• Secondary objectives: Assessment of radiographic response rate by CT scanning, overall survival, time to progression, rate of complete surgical resection and toxicity

• Evaluation of the predictive power of PET to define pathologic response

Interventions

Neoadjuvant Therapy with Cisplatin Plus Docetaxel DRUG

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically confirmed NSCLC appropriate for surgery
• Medically fit for resection by lobectomy or pneumonectomy
• T1-2N1 disease by CT must have negative N2/N3 nodes by PET
• T3N1 disease must have pathologically negative N2/N3 nodes
• Measurable disease
• Patients must not be receiving other investigational therapy
• Prior surgery for NSCLC okay if resected \> or = 5 years prior
• No prior chemotherapy or radiation for NSCLC
• No uncontrolled medical problems
• No factors that would preclude obtaining informed consent
• Age 18 or greater
• Performance status (PS) 0-1
• Peripheral neuropathy must be \< grade 1
• Acceptable hematologic and chemistry parameters
• Renal: creatinine clearance (calculated) \> 50 cc/min

You may not qualify if:

• History of severe hypersensitivity to docetaxel or like drugs
• Pregnant or nursing women
• Prior chemotherapy or radiation for NSCLC
• Symptomatic superior sulcus tumors
• Prior malignancy except for treated non-melanoma skin cancer, in situ cervical cancer, localized prostate cancer or cancer from which the patient has been disease free for greater than three years

Sponsors & Collaborators

• Providence Health & Services: lead
• Providence Cancer Center, Earle A. Chiles Research Institute: collaborator
• Sanofi: collaborator

Study Sites (1)

Providence Portland Medical Center

Portland, Oregon, 97213, United States

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Neoplasms; Neoplasm Metastasis

Interventions

Neoadjuvant Therapy; Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• Brendan Curti, MD

  Director, Lung Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 30, 2005
• First Posted: October 4, 2005
• Study Start: May 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: November 1, 2007
• Last Updated: May 18, 2011

Record last verified: 2011-05

Locations

US (1)