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Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer

This study has been completed.
Information provided by:
National Cancer Institute (NCI) Identifier:
First received: November 1, 1999
Last updated: July 23, 2008
Last verified: July 2007

November 1, 1999
July 23, 2008
April 1998
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Complete list of historical versions of study NCT00003281 on Archive Site
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Topotecan and Paclitaxel in Treating Patients With Recurrent or Refractory Small Cell Lung Cancer
Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer

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 topotecan and paclitaxel in treating patients who have recurrent or refractory small cell lung cancer.


  • Determine the toxicity of combination topotecan and paclitaxel in previously treated patients with small cell lung cancer.
  • Determine the response rate and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to length of time since prior treatment (less than 3 months (stratum A) vs 3 months or more (stratum B)). Stratum A closed to accrual effective 06/20/2000.

Patients receive topotecan IV over 30 minutes on days 1-3 and paclitaxel IV over 3 hours on day 3. Courses repeat every 4 weeks.

Patients who achieve partial response or stable disease continue treatment in the absence of complete response or disease progression. Patients who develop disease progression in the CNS only should receive whole brain radiotherapy and then continue treatment. Patients who achieve complete remission receive a maximum of 6 courses of treatment. Patients may then undergo prophylactic cranial irradiation and/or thoracic radiotherapy at the discretion at the attending physician.

Patients are followed every 3 months for 2 years and then at 3 years after study.

PROJECTED ACCRUAL: A total of 19-55 patients will be accrued for stratum B of this study over 12-21 months. Stratum A closed to accrual effective 06/20/2000.

Phase 2
Primary Purpose: Treatment
Lung Cancer
  • Drug: paclitaxel
  • Drug: topotecan hydrochloride
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Dy GK, Jett JR, Geoffroy FJ, Krewer KD, Tazelaar H, Maurer M, Rowland K, Mailliard J, Krook J, Dakhil S, Kutteh L, Kugler J, Wender D. Topotecan and paclitaxel in previously treated patients with relapsed small cell lung cancer: phase II trial of the North Central Cancer Treatment Group. J Thorac Oncol. 2006 Mar;1(3):211-7. No abstract available.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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  • Stratum A (less than 3 months since prior therapy) closed to accrual effective 06/20/2000)
  • Histologically or cytologically confirmed recurrent or refractory small cell lung cancer

    • Only 1 prior regimen allowed (an alternating regimen with cyclophosphamide/doxorubicin/vincristine and etoposide/cisplatin is acceptable)
  • No mixed histology
  • Measurable or evaluable disease that has not been in the field of prior radiotherapy
  • No uncontrolled CNS metastases (treated CNS metastases eligible)



  • 18 and over

Performance status:

  • ECOG 0-2

Life expectancy:

  • Not specified


  • Absolute neutrophil count at least 2,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Total bilirubin no greater than 1.5 times upper limit of normal (ULN) OR
  • Direct bilirubin normal


  • Creatinine no greater than 1.5 times ULN


  • No unstable angina pectoris
  • No uncontrolled congestive heart failure
  • No myocardial infarction within the past 3 months


  • No uncontrolled infections
  • No other concurrent malignancy except skin cancer or localized prostate cancer
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception


Biologic therapy:

  • Not specified


  • See Disease Characteristics
  • No prior topoisomerase I inhibitor (e.g., topotecan or irinotecan) or taxane (e.g., paclitaxel or docetaxel)
  • At least 3 months since other prior chemotherapy

Endocrine therapy:

  • Not specified


  • See Disease Characteristics
  • At least 2 weeks since prior radiotherapy
  • No concurrent radiotherapy


  • At least 3 weeks since any prior major surgery
18 Years and older
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
CDR0000066190, NCCTG-972051
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North Central Cancer Treatment Group
National Cancer Institute (NCI)
Study Chair: James R. Jett, MD Mayo Clinic
National Cancer Institute (NCI)
July 2007

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