Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Combination Chemotherapy and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II, Phase I	Supportive care, Treatment	Completed	18 and over	NCI	NCCTG-N9923 N9923, NCT00006012

Objectives

1. 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).
2. Determine the two-year survival of this patient population treated with this regimen.
3. Determine the two-year, progression-free local control rate in this patient population treated with this regimen.
4. Assess the tolerability of this treatment regimen in these patients.
5. Determine the antitumor activity of this regimen in these patients.
6. Determine the overall survival and overall time to progression in this patient population treated with this regimen.

Entry Criteria

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

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

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/mm³
• Platelet count at least 100,000/mm³

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:

• FEV₁ 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

Expected Enrollment

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

Outcomes

Survival at 2 years

Local progression-free survival at 2 years
Tolerabiltiy and toxicity
Overall survival
Time to progression

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.

Garces YI, Okuno SH, Schild SE, et al.: 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 67 (4): 995-1001, 2007.[PUBMED Abstract]

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.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Scott Okuno, MD, Protocol chair		Ph: 507-284-2511 Email: okuno.scott@mayo.edu

Registry Information
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
Trial Start Date		2001-02-16
Registered in ClinicalTrials.gov		NCT00006012
Date Submitted to PDQ		2000-05-26
Information Last Verified		2005-11-07
NCI Grant/Contract Number		CA25224

Back to Top