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Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00006012 |
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 |
Drug: amifostine trihydrate Drug: cisplatin Drug: etoposide Drug: filgrastim Drug: paclitaxel Drug: topotecan hydrochloride Procedure: radiation therapy |
Phase I Phase II |
MedlinePlus related topics: | Cancer Lung Cancer |
ChemIDplus related topics: | Filgrastim Etoposide Cisplatin Paclitaxel Topotecan hydrochloride Topotecan Etoposide phosphate Amifostine |
Study Type: | Interventional |
Study Design: | 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 |
Study Start Date: | February 2001 |
OBJECTIVES:
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).
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Limited disease confined to one hemithorax, the ipsilateral supraclavicular fossa, and encompassable within tolerable thoracic radiotherapy field
Measurable disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Pulmonary:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Show 84 Study Locations |
North Central Cancer Treatment Group |
National Cancer Institute (NCI) |
Study Chair: | Scott Okuno, MD | Mayo Clinic |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Garces YI, Okuno SH, Schild SE, Mandrekar SJ, Bot BM, Martens JM, Wender DB, Soori GS, Moore DF Jr, Kozelsky TF, Jett JR. Phase I North Central Cancer Treatment Group Trial-N9923 of escalating doses of twice-daily thoracic radiation therapy with amifostine and with alternating chemotherapy in limited stage small-cell lung cancer. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):995-1001.
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Garces YI, Okuno SH, Schild SE, et al.: A phase I/II NCCTG trial of escalating doses of twice daily thoracic radiation therapy (TRT) in limited-stage small cell lung cancer (LSCLC). [Abstract] J Clin Oncol 23 (Suppl 16): A-7163, 661s, 2005.
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Study ID Numbers: | CDR0000068021, NCCTG-N9923 |
First Received: | July 5, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00006012 |
Health Authority: | United States: Federal Government |
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