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 work in 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 with radiation therapy may kill more cancer cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy before, during, and after radiation therapy in treating patients who have limited-stage small cell lung cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Drug/Agent Toxicity by Tissue/Organ Lung Cancer Radiation Toxicity |
Biological: filgrastim Drug: amifostine trihydrate Drug: cisplatin Drug: etoposide Drug: paclitaxel Drug: topotecan hydrochloride Radiation: radiation therapy |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Official Title: | 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 |
- Survival at 2 years [ Designated as safety issue: No ]
- Local progression-free survival at 2 years [ Designated as safety issue: No ]
- Tolerabiltiy and toxicity [ Designated as safety issue: Yes ]
- Overall survival [ Designated as safety issue: No ]
- Time to progression [ Designated as safety issue: No ]
| Study Start Date: | February 2001 |
OBJECTIVES:
- 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 5/27/2004).
- 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).
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 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
PATIENT CHARACTERISTICS:
Age:
- 18 and over
Performance status:
- ECOG 0-2
Life expectancy:
- At least 12 weeks
Hematopoietic:
- Absolute neutrophil count at least 1,500/mm^3
- Platelet count at least 100,000/mm^3
Hepatic:
- Bilirubin no greater than 1.5 times upper limit of normal (ULN)
- AST no greater than 3 times ULN
Renal:
- Creatinine no greater than 1.5 times ULN
Cardiovascular:
- No New York Heart Association class III or IV heart disease
Pulmonary:
- FEV_1 at least 40% of predicted AND at least 1 liter
Other:
- 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
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- Not specified
Radiotherapy
- No prior hemithorax radiotherapy
Surgery
- Not specified
Other
- No prior therapy for small cell lung cancer
Contacts and Locations
Show 84 Study Locations| Study Chair: | Scott Okuno, MD | Mayo Clinic |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00006012 History of Changes |
| Other Study ID Numbers: | CDR0000068021, NCCTG-N9923 |
| Study First Received: | July 5, 2000 |
| Last Updated: | May 9, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Cancer Institute (NCI):
|
drug/agent toxicity by tissue/organ radiation toxicity limited stage small cell lung cancer |
Additional relevant MeSH terms:
|
Lung Neoplasms Small Cell Lung Carcinoma Radiation Injuries Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Wounds and Injuries Etoposide phosphate Cisplatin Etoposide |
Paclitaxel Topotecan Amifostine Lenograstim Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Radiation-Protective Agents Protective Agents Antineoplastic Agents, Phytogenic Tubulin Modulators Antimitotic Agents Mitosis Modulators |
ClinicalTrials.gov processed this record on May 23, 2013