Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00087048
First received: July 8, 2004
Last updated: December 17, 2013
Last verified: October 2006

July 8, 2004
December 17, 2013
April 2004
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Overall survival [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00087048 on ClinicalTrials.gov Archive Site
  • Safety and toxic effects [ Designated as safety issue: Yes ]
  • Recurrence-free survival [ Designated as safety issue: No ]
  • Time to response and tumor response [ Designated as safety issue: No ]
  • Quality of life [ Designated as safety issue: No ]
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Topotecan in Treating Patients With Recurrent Extensive-Stage Small Cell Lung Cancer
The Use Of Weekly Topotecan As Second Line Therapy In Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: This phase II trial is studying how well high-dose topotecan works as second-line therapy in treating patients with recurrent extensive-stage small cell lung cancer.

OBJECTIVES:

Primary

  • Determine the overall survival of patients with recurrent extensive stage small cell lung cancer treated with high-dose topotecan hydrochloride.

Secondary

  • Determine the safety and toxic effects of this drug in these patients.
  • Determine the recurrence-free survival of patients treated with this drug.
  • Determine time to response and tumor response in patients treated with this drug.
  • Determine the quality of life of patients treated with this drug.

OUTLINE: This is a non-randomized, multicenter study.

Patients receive high-dose topotecan hydrochloride IV over 30 minutes on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 56 days for 4 courses in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, day 1 of each course (except course 1), at the end of study treatment, and then every 3 months thereafter.

Patients are followed at 7-14 days and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 65 patients will be accrued for this study.

Interventional
Phase 2
Masking: Open Label
Primary Purpose: Treatment
Lung Cancer
Drug: topotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
65
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DISEASE CHARACTERISTICS:

  • Histologically confirmed small cell lung cancer (SCLC)

    • Recurrent extensive stage disease
    • No mixed histology
  • Measurable disease

    • At least 1 bidimensionally measurable, non-CNS, indicator lesion confirmed by CT scan or MRI
  • Sensitive disease

    • Responded to prior first-line therapy AND relapsed ≥ 60 days after response (90 days after initiation of first-line therapy)
  • Eligible for high-dose chemotherapy
  • No symptomatic brain metastases affecting performance status

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • At least 2 months

Hematopoietic

  • Absolute neutrophil count ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 9.0 g/dL
  • Hematocrit > 35% (without transfusion)

Hepatic

  • SGOT and SGPT ≤ 2 times normal*
  • Alkaline phosphatase ≤ 2 times normal*
  • Bilirubin ≤ 2.0 mg/dL
  • Albumin > 2.5 g/dL
  • Hepatitis B surface antigen negative
  • No significant hepatic disease NOTE: *≤ 5 times upper limit of normal if liver metastases are present

Renal

  • Creatinine clearance ≥ 40 mL/min

Cardiovascular

  • No history of cardiac arrhythmias
  • No congestive heart failure
  • No ischemic heart disease
  • No stroke or other embolic disease requiring daily treatment that would preclude study participation

Other

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for 3 months after study participation
  • HIV negative
  • No known seizure disorder
  • No active infection requiring systemic therapy within the past 2 weeks
  • No known hypersensitivity to topotecan hydrochloride
  • No medical or psychiatric condition that would preclude study participation
  • No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or stage A low-grade prostate cancer

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • More than 4 weeks since prior antineoplastic and/or myelosuppressive chemotherapy
  • No more than 1 prior chemotherapy regimen (except for adjuvant chemotherapy) for SCLC
  • No prior topotecan hydrochloride

Endocrine therapy

  • Not specified

Radiotherapy

  • Not specified

Surgery

  • Not specified

Other

  • More than 2 months since prior investigational agent
  • No other concurrent investigational agent
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00087048
CDR0000372872, CASE-HFHS-1503, HFH-HFHS-1503, HFH-HFHS-0205, CWRU-050308
Not Provided
Not Provided
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: Afshin Dowlati, MD Case Comprehensive Cancer Center
National Cancer Institute (NCI)
October 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP