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Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant Cisplatin/Etoposide and Amifostine in Limited-Stage Small Cell Lung Cancer

Phase 1/Phase 2
18 Years
Not Enrolling
Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Radiation Toxicity

Thank you

Trial Information

Phase I-II Study of Topotecan and Paclitaxel Followed by High-Dose Thoracic Radiation Therapy With Concomitant Cisplatin/Etoposide and Amifostine in Limited-Stage Small Cell Lung Cancer


- Determine the maximum tolerated dose of thoracic radiotherapy administered with
cisplatin, etoposide, and amifostine preceded and followed by topotecan and paclitaxel
in patients with limited stage small cell lung cancer (phase I closed to accrual as of

- Determine the two-year survival of this patient population treated with this regimen.

- Determine the two-year, progression-free local control rate in this patient population
treated with this regimen.

- Assess the tolerability of this treatment regimen in these patients.

- Determine the antitumor activity of this regimen in these patients.

- Determine the overall survival and overall time to progression in this patient
population treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of thoracic radiotherapy (TRT).

Patients receive topotecan IV on days 1-5 and paclitaxel IV over 3 hours on day 5. Patients
receive filgrastim (G-CSF) subcutaneously (SC) daily beginning 24 hours after the last dose
of chemotherapy and continuing until blood counts recover. Treatment repeats every 3 weeks
for 2 courses.

After 2 courses of topotecan and paclitaxel, patients undergo TRT twice daily for 5
consecutive days for 5 weeks. During TRT, patients receive cisplatin IV, oral etoposide, and
amifostine SC daily prior to TRT.

At 4 weeks after completion of TRT, patients receive 2 additional courses of topotecan,
paclitaxel, and G-CSF every 3 weeks followed by prophylactic cranial irradiation.

Cohorts of 3-6 patients receive escalating doses of TRT until the maximum tolerated dose
(MTD) is determined. The MTD is defined as the dose preceding that at which at least 2 of 6
patients experience dose-limiting toxicity (phase I closed to accrual as of 5/27/2004).

Patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6
months for 3 years.

PROJECTED ACCRUAL: A total of 3-73 patients will be accrued for this study (phase I closed
to accrual as of 5/27/2004).

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer

- Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa,
and encompassable within tolerable thoracic radiotherapy field

- Minimal pleural effusions (i.e., blunting of the costophrenic angle on chest
x-ray or a small effusion on CT scan) allowed

- Measurable disease

- At least one lesion accurately measured in at least 1 dimension with longest
diameter at least 20 mm



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- AST no greater than 3 times ULN


- Creatinine no greater than 1.5 times ULN


- No New York Heart Association class III or IV heart disease


- FEV_1 at least 40% of predicted AND at least 1 liter


- No uncontrolled infection

- No other severe underlying diseases

- No other malignancy within the past 5 years except adequately treated basal cell or
squamous cell skin cancer or noninvasive carcinomas (carcinoma in situ)

- No grade 2 or greater peripheral neuropathy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No hypersensitivity to E.coli-derived proteins, filgrastim (G-CSF), or any excipients
of G-CSF


Biologic therapy

- Not specified


- Not specified

Endocrine therapy

- Not specified


- No prior hemithorax radiotherapy


- Not specified


- No prior therapy for small cell lung cancer

Type of Study:


Study Design:

Primary Purpose: Treatment

Outcome Measure:

Survival at 2 years

Safety Issue:


Principal Investigator

Scott Okuno, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

Related Keywords:

  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • Radiation Toxicity
  • drug/agent toxicity by tissue/organ
  • radiation toxicity
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Injuries



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