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Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study has been completed.
First Received: February 14, 2002   Last Updated: July 23, 2008   History of Changes
Sponsor: Southwest Oncology Group
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00030433
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Drug: gemcitabine hydrochloride
Drug: irinotecan hydrochloride
Phase II

Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Trial Of Gemcitabine (NSC-613327) And Irinotecan (NSC-616348) In Patients With Untreated Extensive Stage Small Cell Lung Cancer (SCLC)

Resource links provided by NLM:


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

Study Start Date: January 2002
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.

  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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00030433

  Show 102 Study Locations
Sponsors and Collaborators
Southwest Oncology Group
Investigators
Study Chair: Wallace L. Akerley, MD Boston Medical Center
  More Information

Additional Information:
Publications:
Study ID Numbers: CDR0000069165, SWOG-S0119
Study First Received: February 14, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00030433     History of Changes
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Thoracic Neoplasms
Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Immunologic Factors
Carcinoma, Neuroendocrine
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Neoplasms, Nerve Tissue
Irinotecan
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Gemcitabine
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Immunosuppressive Agents
Antiviral Agents
Camptothecin
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on November 05, 2009