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Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

This study has been completed.
Study NCT00030433.   Last updated on July 23, 2008.   Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title  Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)
Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

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

Detailed Description

OBJECTIVES:

  • Determine the survival of patients with extensive stage small cell lung cancer treated with gemcitabine and irinotecan.
  • Determine the response rates (confirmed and unconfirmed, complete and partial) of patients treated with this regimen.
  • Determine the overall toxic effects of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients receive gemcitabine IV over 30 minutes followed by irinotecan IV over 90 minutes on days 1 and 8. Treatment repeats every 21 days for a total of 6 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study within 12 months.

Study Phase Phase II
Study Type  Interventional
Study Design  Treatment
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Lung Cancer
Intervention  Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
MEDLINE PMIDs 17545848
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Completed
Enrollment 
Start Date  January 2002
Completion Date
Eligibility Criteria 

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed extensive stage small cell lung cancer (SCLC)

    • Malignant pleural effusion constitutes extensive stage disease
  • Must have disease outside area of prior surgical resection or a new lesion must be present
  • Controlled brain metastases allowed (asymptomatic and previously treated with surgery and/or radiotherapy)

    • Brain metastases must be re-evaluated by CT scan or MRI after completion of radiotherapy or surgery

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-2

Life expectancy:

  • Not specified

Hematopoietic:

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

Hepatic:

  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • SGOT or SGPT no greater than 2.5 times ULN

Renal:

  • Not specified

Other:

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

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No prior biologic therapy for SCLC

Chemotherapy:

  • No prior systemic chemotherapy for SCLC

Endocrine therapy:

  • Not specified

Radiotherapy:

  • See Disease Characteristics
  • No prior radiotherapy for SCLC except for brain metastases

Surgery:

  • See Disease Characteristics
  • At least 2 weeks since prior surgery (thoracic or other major surgery) and recovered
Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00030433
Organization ID CDR0000069165
Secondary IDs †† SWOG-S0119
Study Sponsor  Southwest Oncology Group
Collaborators †† National Cancer Institute (NCI)
Investigators 
Study Chair:     Wallace L. Akerley, MD     Boston Medical Center    
Information Provided By National Cancer Institute (NCI)
Verification Date April 2003
First Received Date  February 14, 2002
Last Updated Date July 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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