Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
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Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy and radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and radiation therapy in treating patients who have limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Lung Cancer |
Biological: filgrastim Drug: carboplatin Drug: etoposide Drug: paclitaxel Drug: topotecan hydrochloride Radiation: radiation therapy |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | Paclitaxel/Topotecan/Etoposide (EtopoTax) Induction Followed by Consolidation Chemoradiotherapy for Limited Stage Small Cell Lung Cancer: A Phase II Study |
| Enrollment: | 65 |
| Study Start Date: | September 2001 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | January 2007 (Final data collection date for primary outcome measure) |
OBJECTIVES:
- 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 months.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- Not specified
Hematopoietic:
- Granulocyte count at least 1,500/mm3
- Platelet count at least 100,00/mm3
Hepatic:
- Bilirubin less than 1.5 mg/dL
- SGOT less than 2 times upper limit of normal (ULN)
Renal:
- Creatinine no greater than ULN
- Creatinine clearance no greater than 150 mL/min for men or 130 mL/min for women
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
- No concurrent filgrastim (G-CSF) during consolidation therapy
Chemotherapy:
- 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
Radiotherapy:
- See Disease Characteristics
- No prior chest radiotherapy
Surgery:
- Not specified
Contacts and Locations
Show 51 Study Locations| Study Chair: | Antonius A. Miller, MD | Comprehensive Cancer Center of Wake Forest University |
More Information
Additional Information:
Publications:
| Responsible Party: | Monica M Bertagnolli, MD, Cancer and Leukemia Group B |
| ClinicalTrials.gov Identifier: | NCT00033696 History of Changes |
| Other Study ID Numbers: | CDR0000069313, U10CA031946, CLB-30002 |
| Study First Received: | April 9, 2002 |
| Last Updated: | March 7, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Cancer and Leukemia Group B:
|
limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Etoposide Paclitaxel Etoposide phosphate Carboplatin Topotecan |
Lenograstim Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Topoisomerase I Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Adjuvants, Immunologic Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013