A Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer (LA-NSCLC) (RT0801)

Non-Small Cell Lung Cancer Clinical Trial

— NSCLC  

Official title:

A Phase II Study of Pemetrexed Plus Carboplatin Combined With Radiation in Patients With Inoperable Locally Advanced Non-small Cell Lung Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00886678
• Other study ID #: ZhejiangCH01
• Status: Active, not recruiting
• Phase: Phase 2
• First received: March 31, 2009
• Last updated: February 23, 2011
• Start date: July 2008
• Est. completion date: July 2010

Study information

• Verified date: March 2010
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Patients with inoperable Non-Small-Cell Lung Cancer will receive thoracic radiation therapy 66 Gy over 33 fractions,and concurrent with 2 cycles of chemotherapy with pemetrexed (500 mg/m2,d1,repeated every 3 weeks)and carboplatin (AUC=5,d1,repeated every 3 weeks).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 63
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Histologically proven non-small cell lung cancer (non-squamous cell carcinoma)

• Presence of measurable disease by RECIST

• Inoperable stage IIIA or IIIB

• ECOG performance status 0-1

• No prior chemotherapy, radiation therapy to chest, immunotherapy, or biologic therapy

• Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

Exclusion Criteria:

• Carcinoid tumor, small cell carcinoma of lung

• Patients with any distant metastasis

• History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix Any other morbidity or situation with contraindication for chemotherapy (e.g. active infection, myocardial infarction preceding 6 months, symptomatic heart disease including unstable angina, congestive heart failure or uncontrolled arrhythmias, immunosuppressive treatment)

• Pregnant or lactating women, women who has not taken test of pregnancy (within 14 days before the first administration) and pregnant women

• Women and men of childbearing potential who have no willing of employing adequate contraception

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Drug:
• pemetrexed
500 mg/m2, IV, q 21 days x 2 cycles
• carboplatin
AUC=5,IV,q 21 days x 2 cycles

Radiation:
• thoracic radiation
66 Gy over 33 fractions

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor response rate		Tumor assessments after completion of chemoradiotherapy and every 2 months	No
Secondary	overall survival		baseline to date of death from any cause	Yes
Secondary	time to progressive disease		baseline to measured progressive disease	No
Secondary	the safety profile		every cycle	Yes
Secondary	site of first failure in patients who develop progressive disease		baseline to measured progressive disease	No