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A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide

Phase 2
18 Years
Not Enrolling
Extensive Stage Small Cell Lung Cancer

Thank you

Trial Information

A Randomized Phase II Study: Sequencing Topoisomerase Inhibitors for Extensive Stage Small Cell Lung Cancer (SCLC): Topotecan Sequenced With Etoposide/Cisplatin, and Irinotecan/Cisplatin Sequenced With Etoposide



- Evaluate the response frequency of patients with extensive stage small cell lung cancer
treated with topotecan, cisplatin, and etoposide and with irinotecan, cisplatin, and

- Evaluate the toxic effects of these regimens in these patients.

- Evaluate the duration of response and survival of patients treated with these regimens.


- To investigate the occurrence of various breast cancer resistance protein (BCRP)
alleles in patients receiving topoisomerase 1 inhibitors and their impact on clinical
response and toxicity.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2
treatment arms.

- Arm I (PET): Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3;
etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on
days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and
continuing until blood counts recover.

- Arm II (PIE): Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60
minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10.

In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

ACTUAL ACCRUAL: A total of 140 patients were accrued for this study.

Inclusion Criteria


- Extensive stage small cell lung cancer (SCLC) with measurable disease, evaluated
within 2 weeks prior to randomization

- Eastern Cooperative Oncology Group (ECOG) performance status of 0-3

- Disease-free for >=5 years if had a prior second malignancy other than treated basal
cell or squamous cell skin cancer, or carcinoma in situ of the cervix

- Adequate hematologic, hepatic and renal function determined by the following tests,
within 4 weeks prior to randomization: white blood cell (WBC) >=4000/mm3 and
platelets >=100,000/mm3; bilirubin <= upper limit of normal; serum glutamic pyruvate
transaminase (SGPT) or alanine transaminase (ALT) and serum glutamic oxaloacetic
transaminase (SGOT) or aspartate transaminase( AST) <=2.5 x upper limit of normal if
no demonstrable liver metastases or <=5 times upper limit of normal in the presence
of liver metastases; Calculated creatinine clearance >=30 using the formulas in the

- Age 18 and older

- Strongly advised to use an accepted and effective method of contraception

- Those with central nervous system (CNS) metastases were eligible if the metastases
were treated without advancing symptoms prior to the initiation of chemotherapy

- Those receiving erythropoietin could continue to receive it


- Prior radiotherapy for lung cancer; Prior radiotherapy allowed only for central
nervous system (CNS) metastases

- Prior chemotherapy for this disease

- Pregnant or lactating

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Proportion of Patients With Objective Response by Solid Tumor Response Criteria (RECIST)

Outcome Description:

Per RECIST criteria, Complete response (CR)= disappearance of all target and nontarget lesions Partial response (PR)= >=30% decrease in the sum of the longest diameters of target lesions from baseline, and persistence of one or more non-target lesion(s) and/or the maintenance of tumor marker level above the normal limits. Objective response = CR + PR

Outcome Time Frame:

Assessed every 6 weeks while on treatment, and then every 3 months for patients < 2 years from study entry, every 6 months if patient is 2-3 years from study entry.

Safety Issue:


Principal Investigator

Joseph Aisner, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Cancer Institute of New Jersey


United States: Federal Government

Study ID:




Start Date:

March 2004

Completion Date:

August 2012

Related Keywords:

  • Extensive Stage Small Cell Lung Cancer
  • extensive stage small cell lung cancer
  • Topotecan
  • Etoposide
  • Cisplatin
  • Irinotecan
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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