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Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer
This study is ongoing, but not recruiting participants.
First Received: July 8, 2002   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Ireland Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00041015
  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. It is not yet known which combination chemotherapy regimen is more effective in treating extensive-stage small cell lung cancer.

PURPOSE: Randomized phase III trial to compare different chemotherapy regimens in treating patients who have extensive-stage small cell lung cancer.


Condition Intervention Phase
Lung Cancer
Drug: cisplatin
Drug: etoposide
Drug: topotecan hydrochloride
Phase III

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Cisplatin Etoposide Etoposide phosphate Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: An Open-Label, Multicenter, Randomized, Phase III Study Comparing Oral Topotecan/Cisplatin Versus Etoposide/Cisplatin As Treatment For Chemotherapy-Naive Patients With Extensive Disease - Small Cell Lung

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

Study Start Date: September 2002
Detailed Description:

OBJECTIVES:

  • Compare the overall survival of patients with chemotherapy-naive extensive stage small cell lung cancer treated with cisplatin and oral topotecan vs cisplatin and etoposide.
  • Compare the response rates, response duration, and time to progression in patients treated with these regimens.
  • Compare the tolerability of these regimens in these patients.
  • Compare the patient-perceived disease status and well being in patients treated with these regimens.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to gender, ECOG performance status (0 vs 1 vs 2), lactate dehydrogenase (less than 1.5 times upper limit of normal (ULN) vs 1.5 times ULN or greater), and country. Patients are randomized to 1 of 2 treatment arms.

  • Arm I: Patients receive oral topotecan once daily on days 1-5 and cisplatin IV on day 5.
  • Arm II: Patients receive cisplatin IV on day 1 and etoposide IV over at least 30 minutes on days 1-3.

Treatment in both arms repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, prior to each course, at 4 weeks after study, and then every 4 weeks for 16 weeks.

Patients are followed at 4 weeks, every 4 weeks for 16 weeks, and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 760 patients (380 per treatment arm) will be accrued for this study within 18 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 carcinoma (SCLC)
  • No prior chemotherapy for SCLC OR
  • No chemotherapy within 5 years of diagnosis of SCLC
  • Prior radiotherapy to measurable or nonmeasurable disease field allowed provided radiotherapy was completed at least 6 weeks ago and the disease is demonstrated to be progressing
  • No clinical signs or symptoms of brain and/or leptomeningeal metastases by CT scan or MRI

    • Brain and/or leptomeningeal metastases that are asymptomatic on neurologic exam are allowed provided metastases do not require corticosteroid therapy to control symptoms

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Hemoglobin at least 9.0 g/dL
  • WBC at least 3,500/mm3
  • Platelet count at least 100,000/mm3
  • Neutrophil count at least 1,500/mm3

Hepatic:

  • Bilirubin no greater than 2.0 mg/dL
  • SGOT and SGPT no greater than 2 times the upper limit of normal (ULN) (5 times ULN if liver metastases present)
  • Alkaline phosphatase no greater than 2 times ULN (5 times ULN if liver metastases present)

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Creatinine clearance at least 60 mL/min
  • No pre-existing renal impairment that would preclude cisplatin use

Gastrointestinal:

  • No clinical evidence of any gastrointestinal (GI) conditions including:

    • Removal of a portion of the stomach
    • History of recent obstruction of the GI tract
    • GI autonomic neuropathy
    • Ulcerative colitis
    • Crohn's disease
    • Malabsorption syndrome
    • Treatment with cyclosporine that would alter absorption or GI motility
  • No other conditions that would preclude absorption of oral topotecan

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 3 months prior to study, during, and for at least 1 month after study
  • No active infection
  • No other prior or concurrent malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or localized low-grade prostate cancer
  • No other concurrent severe medical problems that would expose the patient to extreme risk or preclude study compliance
  • No prior allergic reactions to compounds chemically related to study drugs
  • No pre-existing hearing impairment that would preclude cisplatin use
  • No overall medical condition for which study drugs would be inappropriate

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • No concurrent immunotherapy for SCLC

Chemotherapy:

  • See Disease Characteristics
  • No other concurrent chemotherapy for SCLC

Endocrine therapy:

  • See Disease Characteristics
  • No concurrent hormonal therapy for SCLC

Radiotherapy:

  • See Disease Characteristics
  • At least 24 hours since prior radiotherapy with no expected bone marrow suppression
  • Recovered from prior palliative radiotherapy (e.g, nausea and vomiting from radiation of the epigastrium)
  • No concurrent radiotherapy for SCLC
  • No concurrent radiotherapy for palliation of bone metastases or CNS lesions unless approved by the investigator

Surgery:

  • At least 3 weeks since prior major surgery (a shorter period is allowed if deemed in the best interest of the patient)

Other:

  • More than 30 days or 5 half-lives (whichever is longer) since prior investigational drugs
  • No other concurrent investigational therapy for SCLC
  • No concurrent cyclosporine
  • No concurrent drugs that would preclude absorption of oral topotecan
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00041015

Locations
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Ireland Cancer Center
Investigators
Study Chair: Nathan Levitan, MD Case Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000069435, CWRU-070144, SB-389, SB-SKF-104864A, SB-SKF-1501, NCI-G02-2092
Study First Received: July 8, 2002
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00041015     History of Changes
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Thoracic Neoplasms
Carcinoma, Neuroendocrine
Etoposide phosphate
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Radiation-Sensitizing Agents
Cisplatin
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Topotecan
Adenocarcinoma
Antineoplastic Agents, Phytogenic
Etoposide
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Molecular Mechanisms of Pharmacological Action
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Neoplasms by Site
Respiratory Tract Diseases
Cisplatin
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Therapeutic Uses
Etoposide
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Enzyme Inhibitors
Pharmacologic Actions
Neuroendocrine Tumors
Carcinoma
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Radiation-Sensitizing Agents
Lung Diseases
Adenocarcinoma
Topotecan
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009