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

This study has been terminated.
(study terminated due to slow accrual)
Sponsor:
Collaborators:
Providence Cancer Center, Earle A. Chiles Research Institute
Sanofi
Information provided by:
Providence Health & Services
ClinicalTrials.gov Identifier:
NCT00232206
First received: September 30, 2005
Last updated: May 17, 2011
Last verified: May 2011
  Purpose

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 Intervention Phase
Non-small-Cell Lung Carcinoma
Drug: Neoadjuvant Therapy with Cisplatin Plus Docetaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Providence Health & Services:

Primary Outcome Measures:
  • 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:
  • 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

Estimated Enrollment: 40
Study Start Date: May 2005
Estimated Study Completion Date: November 2007
Primary Completion Date: April 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232206

Locations
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
Sanofi
Investigators
Principal Investigator: Brendan Curti, MD Director, Lung Research
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00232206     History of Changes
Other Study ID Numbers: PPMC-EACRI-IRB-05-032, IIT #12207
Study First Received: September 30, 2005
Last Updated: May 17, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Providence Health & Services:
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)

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 18, 2014