Expired Study
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Tucson, Arizona 85724


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.


Study summary:

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.


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


Study is Available At:


Original ID:

CDR0000068516


NCT ID:

NCT00014196


Secondary ID:

S0022


Study Acronym:


Brief Title:

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


Official Title:

Phase II Trial of Concurrent Cisplatin/Docetaxel and Radiotherapy Followed by Consolidation Docetaxel in Stage IIIB Non-Small Cell Lung Cancer


Overall Status:

Terminated


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Southwest Oncology Group


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:

This study was closed early due to poor accr


Study Type:

Interventional


Study Design:

Endpoint Classification: Safety/Efficacy Study, I


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

33


Enrollment Type:

Actual


Overall Contact Information

Official Name:Raja Mudad, MD, FACP
Study Chair
Tulane University Health Sciences Center

Study Dates

Start Date:March 2001
Completion Date:March 2005
Completion Type:Actual
Primary Completion Date:March 2005
Primary Completion Type:Actual
Verification Date:February 2013
Last Changed Date:February 12, 2013
First Received Date:April 10, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:cisplatin
Arm Name:chemo/RT followed by consolidation chemo
Intervention Type:Drug
Name:docetaxel
Arm Name:chemo/RT followed by consolidation chemo
Intervention Type:Radiation
Name:radiation therapy
Arm Name:chemo/RT followed by consolidation chemo

Study Arms

Study Arm Type:Experimental
Arm Name:chemo/RT followed by consolidation chemo
Description:cisplatin docetaxel radiation therapy

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Southwest Oncology Group
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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