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

NCT00886678 | Unknown Phase 2 DMC

• 1 other identifier: ZhejiangCH01
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Non-Small Cell Lung Cancer

Keywords

Non-Small Cell Lung Cancer; pemetrexed; radiation

Outcome Measures

Primary Outcomes (1)

• tumor response rate

  Tumor assessments after completion of chemoradiotherapy and every 2 months

Secondary Outcomes (4)

• overall survival

  baseline to date of death from any cause

• time to progressive disease

  baseline to measured progressive disease

• the safety profile

  every cycle

• site of first failure in patients who develop progressive disease

  baseline to measured progressive disease

Study Arms (1)

1

EXPERIMENTAL

patients receiving pemetrexed, carboplatin and radiation therapy.

Drug: pemetrexed; Drug: carboplatin; Radiation: thoracic radiation

Interventions

pemetrexed DRUG

500 mg/m2, IV, q 21 days x 2 cycles

1

carboplatin DRUG

AUC=5,IV,q 21 days x 2 cycles

1

thoracic radiation RADIATION

66 Gy over 33 fractions

1

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Zhejiang Cancer Hospital: lead

Study Sites (1)

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, 310022, China

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Carboplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Coordination Complexes; Organic Chemicals

Study Officials

• Ma Sheng lin, MD

  Zhejiang Cancer Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2009
• First Posted: April 23, 2009
• Study Start: July 1, 2008
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: February 24, 2011

Record last verified: 2010-03

Locations

CN (1)