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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00232206
Recruitment Status : Terminated (study terminated due to slow accrual)
First Posted : October 4, 2005
Last Update Posted : May 18, 2011
Providence Cancer Center, Earle A. Chiles Research Institute
Information provided by:
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Non-small-Cell Lung Carcinoma Drug: Neoadjuvant Therapy with Cisplatin Plus Docetaxel Phase 2

Detailed Description:

Non-small cell lung cancer (NSCLC) accounts for 80% of new lung cancer diagnoses in the US. Surgery is the primary most successful treatment for early stage patients. However, even lung cancers caught at an early stage (stage IB through selected IIIA) have 5 year survivals after surgery at a rate of only 10-60%. Postoperative platinum based chemotherapy offers a 4-15% survival benefit, depending on stage in fit patients after complete surgical removal of early stage disease. Preoperative platinum based chemotherapy has been shown in small randomized trials to benefit patients with stage IIIA, N2 positive disease, but is not standard of care in earlier stage disease, such as the population in this study.

The combination of cisplatin and docetaxel is approved in the US for front line therapy of stage IV NSCLC based on randomized clinical data showing efficacy and manageable toxicity. Given the efficacy and tolerance of this combination in the metastatic setting, this regimen is an obvious choice for study in the neoadjuvant setting.

PET imaging is approved in the US for determining size, site and spread of lung cancer (staging) and has been shown to reduce unnecessary surgery when used as part of preoperative evaluation. Because NSCLC is not 100% responsive to chemotherapy and CT scans may not show a change in tumor size until after several cycles of chemotherapy, PET imaging might be an effective way to provide an earlier and more reliable estimate of response.

Preoperative chemotherapy will be given for a total of two cycles 21 days apart if any adverse events have resolved and there is no evidence of disease progression. Patients will undergo CT chest through liver and PET scans for restaging following the second cycle and will then be scheduled for surgery 3-6 weeks after the second cycle of chemotherapy. Patients who have responded according to CT and/or PET imaging, or surgical pathology will go on to receive an additional two cycles of chemotherapy with docetaxel and cisplatin once the patient has recovered from surgery.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Cisplatin Plus Docetaxel as Neoadjuvant Therapy for Stages IB Through Selected IIIA NSCLC
Study Start Date : May 2005
Actual Primary Completion Date : April 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Primary Outcome Measures :
  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 Outcome Measures :
  1. Secondary objectives: Assessment of radiographic response rate by CT scanning, overall survival, time to progression, rate of complete surgical resection and toxicity
  2. Evaluation of the predictive power of PET to define pathologic response

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00232206

United States, Oregon
Providence Portland Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
Providence Cancer Center, Earle A. Chiles Research Institute
Principal Investigator: Brendan Curti, MD Director, Lung Research Identifier: NCT00232206     History of Changes
Other Study ID Numbers: PPMC-EACRI-IRB-05-032
IIT #12207
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: May 18, 2011
Last Verified: May 2011

Keywords provided by Providence Health & Services:
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)

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action