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Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed Small Cell Lung Cancer

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Phase II Trial of Topotecan and Paclitaxel in Previously Treated Patients With Relapsed 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.

Inclusion Criteria


- Stratum A (less than 3 months since prior therapy) closed to accrual effective

- Histologically or cytologically confirmed recurrent or refractory small cell lung

- 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

James R. Jett, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

April 1998

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



Mayo Clinic Cancer CenterRochester, Minnesota  55905
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - DuluthDuluth, Minnesota  55805
CCOP - Scottsdale Oncology ProgramScottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
Siouxland Hematology-OncologySioux City, Iowa  51101-1733
CCOP - OchsnerNew Orleans, Louisiana  70121
Altru Health SystemsGrand Forks, North Dakota  58201
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Medcenter One Health SystemBismarck, North Dakota  58501
CentraCare Health PlazaSaint Cloud, Minnesota  56303