ClinicalTrials.gov
 Home    Search    Study Topics    Glossary  
 

  Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

This study is ongoing, but not recruiting participants.

Sponsors and Collaborators: Southwest Oncology Group
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00006487
  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 more than one chemotherapy drug with radiation therapy may kill more tumor cells.

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


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: tirapazamine
Procedure: radiation therapy
Phase I

MedlinePlus related topics:   Cancer    Lung Cancer   

Drug Information available for:   Etoposide    Cisplatin    Etoposide phosphate    Tirapazamine   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment
Official Title:   A Phase I Study Of Tirapazamine/Cisplatin/Etoposide And Concurrent Thoracic Radiotherapy For Limited Stage Small Cell Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:   October 2000

Detailed Description:

OBJECTIVES:

  • Determine the feasibility of tirapazamine, cisplatin, and etoposide concurrently with radiotherapy in patients with limited stage small cell lung cancer.
  • Determine the toxicities of this treatment regimen in these patients.
  • Determine the response rate in these patients treated with this regimen.

OUTLINE: Patients are assigned to one of two induction therapy arms.

  • Arm I: Patients receive induction chemotherapy consisting of low-dose tirapazamine IV over 1 hour and cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients also undergo radiotherapy concurrently with chemotherapy 5 consecutive days a week for 7 weeks beginning on day 1.
  • Arm II: Patients receive induction chemotherapy consisting of high-dose tirapazamine, cisplatin, etoposide, and radiotherapy as in arm I.

Patients with stable or responding disease then receive consolidation therapy consisting of tirapazamine IV over 1 hour and cisplatin IV over 1 hour on day 1 of weeks 11 and 14 and etoposide IV over 1 hour on days 1-3 of weeks 11 and 14.

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

PROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.

  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 limited stage small cell lung cancer (SCLC)
  • No malignant pericardial or pleural effusions, including any of the following:

    • Cytologically positive effusions
    • Exudative effusions not attributable to other etiologies
  • No brain metastases
  • Disease (measurable or non-measurable) must be present outside the area of prior surgical resection

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1

Life expectancy:

  • Not specified

Hematopoietic:

  • Absolute neutrophil count greater than 1,500/mm^3
  • Platelet count greater than 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2 times ULN
  • Alkaline phosphatase no greater than 2 times ULN

Renal:

  • Creatinine no greater than ULN OR
  • Creatinine clearance at least 60 mL/min

Other:

  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No symptomatic sensory neuropathy grade 1 or greater
  • No other malignancy within past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other stage I or II cancer in complete remission
  • No other medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for SCLC

Chemotherapy:

  • No prior systemic chemotherapy for SCLC

Endocrine therapy:

  • Not specified

Radiotherapy:

  • No prior thoracic radiotherapy for SCLC

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior thoracic or other major surgery and recovered
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006487

Show 87 study locations  Show 87 Study Locations

Sponsors and Collaborators
Southwest Oncology Group
National Cancer Institute (NCI)

Investigators
Study Chair:     Quynh-Thu X. Le, MD     Stanford University    
  More Information


Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site
 

Publications of Results:

Study ID Numbers:   CDR0000068318, SWOG-S0004
First Received:   November 6, 2000
Last Updated:   July 23, 2008
ClinicalTrials.gov Identifier:   NCT00006487
Health Authority:   United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
limited stage small cell lung cancer  

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Tirapazamine
Adenocarcinoma
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Radiation-Sensitizing Agents
Antineoplastic Agents
Therapeutic Uses
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 20, 2008




Links to all studies - primarily for crawlers