Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum for Advanced NSCLC

NCT01769066 | Completed Phase 2

• 1 other identifier: Gefitinib-2009-cjh
• Study Type: interventional
• Target: 117
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to explore the Clinical Value of Sequential Gefitinib With Pemetrexed/Platinum compare with Pemetrexed/Platinum for Advanced NSCLC.

Conditions

NSCLC

Outcome Measures

Primary Outcomes (1)

• 12 weeks of non-progression rate

  from the first cycle of treatment (day one) to two month after the last cycle

Secondary Outcomes (1)

• PFS

  from the first cycle of treatment (day one) to two month after the last cycle

Study Arms (2)

Sequential Gefitinib With Pemetrexed/Platinum

EXPERIMENTAL

Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1 Gefitinib PO. 250mg DAY3-16

Drug: Sequential Gefitinib With Pemetrexed/Platinum

Pemetrexed/Platinum

ACTIVE COMPARATOR

Pemetrexed IV 500 mg/m2 ，DAY2 DDP IV 75mg/m2 ，DAY1 OR CAP IV AUC 5,DAY1

Drug: Pemetrexed/Platinum

Interventions

Sequential Gefitinib With Pemetrexed/Platinum DRUG

Sequential Gefitinib With Pemetrexed/Platinum

Pemetrexed/Platinum DRUG

Pemetrexed/Platinum

Eligibility Criteria

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

You may qualify if:

• \~70 years
• Patients who were diagnosed by the histologic, cytologic diagnosis of IIIb-IV non-small cell lung cancer
• Presence of at least one index lesion measurable by CT scan or MRI
• Ecog0-1
• Expected life time longer than 12 weeks
• Normal laboratory values:
• leucocyte ≥ 4×109/L
• neutrophil ≥ 1.5×109/L
• platelet ≥ 100×109/L
• Hemoglobin ≥ 10g/L
• ALT and
• AST ≤ 2.5×ULN (≤ 5×ULN if liver metastasis)
• Signed written informed consent

You may not qualify if:

• Patients have used drugs according to protocol
• Patients were allergic to pemetrexed or cisplatin
• Patients received radiotherapy or other biological treatment 4 weeks before the trial
• Uncontrolled hydrothorax or hydropericardium
• neuropathy toxicity ≥ CTC 3
• Severe symptomatic heart disease
• Active upper gastrointestinal ulcer or digestive disfunction
• Severe infection or metabolic disfunction
• Patients with other malignant tumor
• Uncontrolled brain metastases
• Patients have accepted other clinical trials
• Female patients during their pregnant and lactation period, or patients without contraception

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Cancer hospital Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Interventions

Pemetrexed; Platinum

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; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Chang jian hua, MD,PhD

  Cancer hospital Fudan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Deputy director of department of medical oncology

Study Record Dates

• First Submitted: January 10, 2013
• First Posted: January 16, 2013
• Study Start: December 1, 2009
• Primary Completion: February 1, 2014
• Last Updated: February 23, 2016

Record last verified: 2016-02

Locations

CN (1)