S0022:Combination Chemotherapy and Radiation Therapy in Treating Patients With Stage IIIB Non-Small Cell Lung Cancer

This study has been terminated.
(This study was closed early due to poor accrual.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Southwest Oncology Group
ClinicalTrials.gov Identifier:
NCT00014196
First received: April 10, 2001
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have stage IIIB non-small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: docetaxel
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer

Resource links provided by NLM:


Further study details as provided by Southwest Oncology Group:

Enrollment: 33
Study Start Date: March 2001
Study Completion Date: March 2005
Primary Completion Date: March 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: chemo/RT followed by consolidation chemo
cisplatin docetaxel radiation therapy
Drug: cisplatin Drug: docetaxel Radiation: radiation therapy

Detailed Description:

OBJECTIVES:

  • Determine survival and time to treatment failure in patients with stage IIIB non-small cell lung cancer treated with induction docetaxel, cisplatin, and radiotherapy followed by consolidation docetaxel.
  • Determine the response rate in these patients when treated with this regimen.
  • Determine the toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive induction chemotherapy comprising docetaxel IV over 30 minutes on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 60 minutes on days 1, 8, 29, and 36. Patients also undergo concurrent radiotherapy daily, 5 days per week, for 6.5 weeks.

At least 1 week and no more than 4 weeks after completion of induction chemoradiotherapy, patients with stable or responding disease receive docetaxel IV over 60 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year, every 3 months for 1 year, and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 90 patients will be accrued for this study within 30 months.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed stage IIIB non-small cell lung cancer

    • Adenocarcinoma
    • Large cell carcinoma
    • Squamous cell carcinoma
  • Pathologically or radiographically documented positive N3 nodes

    • No positive supraclavicular or scalene lymph nodes with disease extending into the cervical region OR
  • T4 tumor invading any of the following:

    • Mediastinum
    • Heart
    • Great vessels
    • Trachea
    • Esophagus
    • Vertebral body
    • Carina
  • No brain, contralateral chest, liver, or adrenal metastases
  • No more than 1 parenchymal lesion
  • No malignant pleural effusions unless they are only visible on CT scan or deemed too small to tap
  • No pericardial effusions
  • Measurable disease

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Not specified

Renal:

  • Creatinine clearance at least 50 mL/min

Pulmonary:

  • One of the following:

    • FEV1 at least 2.0 L
    • Predicted FEV1 of contralateral lung greater than 800 mL
    • Predicted post-treatment FEV1 at least 1.0 L

Other:

  • No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
  • Not pregnant or nursing
  • Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent growth factors during induction chemoradiotherapy

Chemotherapy:

  • No prior chemotherapy for lung cancer

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior radiotherapy for lung cancer

Surgery:

  • No prior surgical resection of lung cancer
  • Prior exploratory thoracotomy, mediastinoscopy, excisional biopsy, or similar surgery for determining diagnosis, stage, or potential resectability allowed
  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: NCT00014196

  Show 97 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Raja Mudad, MD, FACP Tulane University Health Sciences Center
  More Information

Additional Information:
No publications provided

Responsible Party: Southwest Oncology Group
ClinicalTrials.gov Identifier: NCT00014196     History of Changes
Other Study ID Numbers: CDR0000068516, S0022, U10CA032102
Study First Received: April 10, 2001
Last Updated: February 12, 2013
Health Authority: United States: Federal Government

Keywords provided by Southwest Oncology Group:
squamous cell lung cancer
large cell lung cancer
stage IIIB non-small cell lung cancer
adenocarcinoma of the lung

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Cisplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 09, 2014