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NCT00494026 Clinical Trial

Chemotherapy and Radiotherapy to Treat Patients With Limited Stage of Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer Clinical Trial

Official title:
Phase II Study of Concurrent Carboplatin, Pemetrexed, and Radiotherapy for Limited Stage of Small Cell Lung Cancer

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00494026
Other study ID # 10015
Secondary ID H3E-MC-S095
Status Terminated
Phase Phase 2
First received June 27, 2007
Last updated November 17, 2009
Start date September 2007
Est. completion date October 2008

Study information
Verified date November 2009
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority Italy: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Spanish Agency of MedicinesTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
Study type Interventional

Clinical Trial Summary

This is a multicenter, phase II, open-label trial to evaluate the efficacy of pemetrexed + carboplatin combined with thoracic radiotherapy in patients with Limited Stage of small cell lung cancer

Description:

Two 21-day cycles of pemetrexed (500 milligrams per square meter [mg/m2] intravenous [IV] infusion) and carboplatin (target area under the curve [AUC] 5 IV infusion) followed by two 21-day cycles of pemetrexed (500 mg/m2 IV infusion) and carboplatin (target AUC 5 IV infusion) with concurrent radiotherapy (2 Gray [Gy] per fraction, 5 fractions per week, up to a dose of 50 Gy is administered).

Recruitment information / eligibility
Status Terminated
Enrollment 4
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Histologic and/or cytologic diagnosis of Limited Stage of small cell lung cancer

- Measurable disease

- Good performance status

- Adequate bone marrow reserve, hepatic, pulmonary and renal functions

Exclusion Criteria:

- Serious concomitant systemic disorder

- Prior chemotherapy for this cancer and/or prior thoracic radiotherapy

- Pregnancy/breast-feeding

- Significant weight loss over the previous 6 weeks before study entry

- Inability or unwillingness to take vitamin supplementation and corticosteroids

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• pemetrexed
500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles
• carboplatin
Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles
Procedure:
• radiotherapy
2 Gray (Gy) per fraction, 5 fractions per week, begin day 1, cycle 3 x 5 weeks (Monday-Friday)

Locations
Country Name City State
Italy For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Orbassano
Italy For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Parma
Italy For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. San Sisto
Italy For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Terni
Poland For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Poznan
Poland For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Warsaw
Spain For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Madrid
Spain For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Palma de Mallorca
Spain For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Valencia
United Kingdom For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Guilford Surrey
United Kingdom For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Southampton Hants
United Kingdom For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Wolverhampton West Midlands

Sponsors (1)
Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

Italy,  Poland,  Spain,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of Patients With a Complete or Partial Response (Overall Response Rate [ORR]) baseline to measured response after chemotherapy and radiation No
Secondary Progression-free Survival baseline to measured progressive disease No
Secondary Overall Survival baseline to date of death from any cause, 1 year Yes
Secondary Duration of Response time of response to progressive disease No
Secondary Pharmacology Toxicity every 21-day cycle for 4 cycles Yes
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