Phase II Docetaxel / Carboplatin / XRT + Surgical Resection in Stage III NSCLC

This study has been terminated.
(low accrual)
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by (Responsible Party):
Heather Wakelee, Stanford University
ClinicalTrials.gov Identifier:
NCT00238615
First received: October 11, 2005
Last updated: May 29, 2013
Last verified: May 2013
  Purpose

The purpose of this study is to assess how well this particular combination of chemotherapy, radiation and surgery works to help people with locally advanced lung cancer, how well PET scans indicates whether someone has responded to chemotherapy and radiation, and gene expression patterns related to outcomes in patients with locally advanced lung cancer who receive this treatment regimen.


Condition Intervention Phase
Lung Cancer
Carcinoma, Non-Small-Cell Lung
Drug: Docetaxel
Drug: Carboplatin
Procedure: Radiation therapy
Procedure: Surgical resection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Trial of Concurrent Docetaxel (Taxotere) / Carboplatin / Radiotherapy Followed by Surgical Resection Followed by Consolidation Taxotere / Carboplatin in Stage III Non-Small Cell Lung Cancer (NSCLC)

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 2 Year Overall Survival After a Combination of Chemotherapy, Radiation and Surgery in Stage III NSCLC Patients Following the Protocol Therapy. [ Time Frame: Two years ] [ Designated as safety issue: Yes ]
    Patients were analyzed for 2 year overall survival after receiving trimodality (chemotherapy/radiation/surgery) therapy for stage III NSCLC. Patients had a chest x-ray and a doctor visit with a physical examination every 3 months after completion of all therapy for 3 years then every 6 months for 3 years to look for evidence of recurrent disease and to follow survival. Thoracic computed tomography (CT) scans were obtained at 6, 12, 18 months after completion of all therapy and then yearly for 3 years or as clinically indicated to evaluate for relapse.


Secondary Outcome Measures:
  • Change in Standard Uptake Value (SUVmax) on Positron Emission Tomography (PET) Scans Pre and Post Chemotherapy and Radiation in This Trial and Ability to Predict Surgical Resection Rate, Progression-free Survival and 2 Year Overall Survival [ Time Frame: baseline, 5 weeks after combined chemo-radiation ] [ Designated as safety issue: No ]
    The change in standardized uptake values (SUV)max on PET scans obtained pre- and after 5 weeks of combined chemo-radiation for patients enrolled on the trial were evaluated for ability to predict outcomes including complete resection at time of surgery (3-6 weeks after completion of the chemo-radiation), progression-free survival and 2 year overall survival. The mean SUVmax pre chemoradiation minus the mean SUVmax post-radiation is reported.


Other Outcome Measures:
  • Exploratory Analysis of Relation of Gene Expression Patterns to Outcomes in Patients With Locally Advanced Lung Cancer Who Receive This Treatment Regimen [ Time Frame: Specimen collected at time of surgery ] [ Designated as safety issue: No ]
    This analysis of gene expression patterns related to outcomes in patients with locally advanced lung cancer who received this treatment regimen was not performed due to lack of funding.


Enrollment: 13
Study Start Date: March 2003
Estimated Study Completion Date: September 2014
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chemotherapy+Radiation+Surgery
  1. Concurrent weekly docetaxel at 20 mg/m2 and weekly carboplatin at an AUC of 2 with thoracic radiotherapy of 180-200cGy/day for 5/7 days to 45 Gy.
  2. Complete surgical excision 3-6 weeks after completion of chemoradiotherapy.
  3. No Surgery if patient is deemed unable to tolerate surgery, with completion to 61 Gy radiation
  4. Consolidation after surgery: Docetaxel given at 75 mg/m2 every 3 weeks with carboplatin at AUC 6 every 3 weeks with concomitant growth factor support.
Drug: Docetaxel
20 mg/m2, 75 mg/m2 infusion
Other Name: Taxotere
Drug: Carboplatin
AUC of 2 and 6 infusion
Other Name: Paraplatin
Procedure: Radiation therapy
NEOADJUVANT RADIOTHERAPY Radiation therapy will be concurrent with the chemotherapy. Radiation therapy will begin within 24 hours of chemotherapy. CONSOLIDATION RADIOTHERAPY Patients with positive surgical margins or incomplete resection (tumor shaved from spine or great vessels) will receive an additional boost of radiotherapy 3 to 6 weeks after surgery. This will be a 16 Gy boost given with concurrent weekly chemotherapy as during the neoadjuvant period.
Other Names:
  • radiation oncology
  • radiotherapy
Procedure: Surgical resection
All patients will be taken to surgical excision, unless they have developed a condition other than progressive disease, which would make surgery unsafe.
Other Names:
  • segmentectomy
  • segmental resection

  Eligibility

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

Inclusion Criteria:

Histologically confirmed stage IIIA or IIIB NSCLC

  • Patients must have measurable disease
  • No previous chemotherapy, radiation therapy or other systemic therapy for their NSCLC.
  • Age>18 years
  • Life expectancy >12 months
  • ECOG performance status 0-1
  • Normal organ and marrow function
  • Medically fit for surgery at time of enrollment.
  • Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of the study. Women must have a negative pregnancy test prior to enrollment.
  • Ability to understand and willingness to sign the consent form.

Exclusion Criteria:

  • Previous chemotherapy, radiation therapy or any other systemic treatment for their NSCLC.
  • Patients receiving any other investigational agents.
  • Known metastatic disease (brain or any other site)
  • History of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 or with allergic reactions to compounds of similar chemical composition to carboplatin or other agents used in the study.
  • Peripheral neuropathy >grade 1
  • Uncontrolled concurrent illness
  • Pregnant women
  • Weight loss>10% in the past 3 months before diagnosis.
  • Hyperglycemia - exclusion from PET analysis
  • HIV positive patients receiving combination anti-retroviral therapy because of possible pharmacokinetic interactions with docetaxel and carboplatin or other agents administered during the study.
  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: NCT00238615

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Aventis Pharmaceuticals
Investigators
Principal Investigator: Heather A. Wakelee Stanford University
  More Information

Publications:
Responsible Party: Heather Wakelee, Assistant Professor of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT00238615     History of Changes
Other Study ID Numbers: LUN0002, 78999, GIA #12169, 11804
Study First Received: October 11, 2005
Results First Received: September 24, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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
Carboplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 20, 2014