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Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study

Phase 2
18 Years
Not Enrolling
Lung Cancer

Thank you

Trial Information

Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study


- Determine the complete and overall response rates in patients with limited stage small
cell lung cancer treated with induction chemotherapy comprising paclitaxel, topotecan,
and etoposide followed by consolidation chemoradiotherapy.

- Determine the toxicity of this regimen in these patients.

- Determine the overall and failure-free survival of patients treated with this regimen.

- Determine the overall (partial and complete) response rate in patients treated with
this induction chemotherapy regimen.

OUTLINE: This is a multicenter study.

- Induction therapy: Patients receive paclitaxel IV over 3 hours on days 1 and 22, oral
topotecan on days 2-4 and 23-25, and oral etoposide on days 5-7 and 26-28. Patients
also receive filgrastim (G-CSF) subcutaneously daily beginning on days 8 and 29 and
continuing until blood counts recover.

- Consolidation therapy: Patients receive carboplatin IV over 1 hour on days 43, 64, and
85 and etoposide IV over 1 hour on days 43-45, 64-66, and 85-87. Patients undergo
radiotherapy daily 5 days per week beginning on day 43 and continuing for 6-7 weeks.

Patients with rapid disease progression discontinue study therapy.

Patients are followed at least every 3 months for 2 years, every 6 months for 3 years, and
then annually for 5 years.

PROJECTED ACCRUAL: A total of 25-60 patients will be accrued for this study within 10

Inclusion Criteria


- Histologically or cytologically confirmed small cell lung cancer

- Limited stage defined as disease restricted to one hemithorax with regional
lymph node metastases including hilar, ipsilateral, and contralateral
mediastinal lymph nodes

- Measurable disease

- At least 20 mm by conventional techniques OR

- At least 10 mm by spiral CT scan

- Lesions not considered measurable include the following:

- Bone lesions

- Leptomeningeal disease

- Ascites

- Pleural/pericardial effusion

- Abdominal masses not confirmed and followed by imaging techniques

- Cystic lesions

- Tumor lesions in a previously irradiated area

- No clinically suspected or confirmed supraclavicular lymph node metastases

- No pleural effusions visible on plain chest radiographs, regardless of cytology



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- Not specified


- Granulocyte count at least 1,500/mm3

- Platelet count at least 100,00/mm3


- Bilirubin less than 1.5 mg/dL

- SGOT less than 2 times upper limit of normal (ULN)


- Creatinine no greater than ULN

- Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No other currently active malignancy except non-melanoma skin cancer

- Patients must have completed therapy for any other malignancy and be considered to be
at less than 30% risk of relapse


Biologic therapy:

- No concurrent filgrastim (G-CSF) during consolidation therapy


- No prior chemotherapy for small cell lung cancer

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy except:

- Steroids for adrenal failure

- Hormones for non-disease-related conditions (e.g., insulin for diabetes)

- Intermittent use of dexamethasone as an antiemetic or as an adjunct to
prophylactic cranial irradiation


- See Disease Characteristics

- No prior chest radiotherapy


- Not specified

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




Start Date:

September 2001

Completion Date:

April 2009

Related Keywords:

  • Lung Cancer
  • limited stage small cell lung cancer
  • Lung Neoplasms
  • Small Cell Lung Carcinoma



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