Text Size

Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non-small Cell Lung Cancer (AP/GP)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Li Zhang, Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01194453
First received: August 25, 2010
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

A phase III trial has demonstrated that in advanced non-small cell lung cancer (NSCLC) cisplatin/ pemetrexed provides similar efficacy with better tolerability and more convenient administration than cisplatin/gemcitabine. Moreover,this trial showed survival differences based on histologic type. The investigators want to research some biomarkers that can predict clinical outcomes.


Condition Intervention Phase
Non-small Cell Lung Cancer
Efficacy
 Drug: cisplatin, dexamethasone,vitamin B12, folic acid
Drug: cisplatin, gemcitabine
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2,Open-label Study of First Line Pemetrexed Plus Cisplatin Versus Gemcitabine Plus Cisplatin for Advanced and Metastatic Non Small Cell Lung Cancer and Biomarker Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • Progression free survival (PFS) [ Time Frame: 36months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • one year survival rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Response Rate [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • Percentage of patients with various adverse events such as bone marrow suppression and non-hematologic toxicity. [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]
  • The expression of thymidylate synthetase (TS) in tumor tissues. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The expression of Excision Repair Cross Complement Group 1（ERCCI）in tumor tissues. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The expression of Ribonucleotide Reductase M1 （RRMI）in tumor tissues. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • The relationship between the expression of TS, ERCCI, RRM1 in tumor tissues and the clinical outcomes of the patients. [ Time Frame: 36 months ] [ Designated as safety issue: No ]
    The investigator would analyze whether the expression level of TS,ERCC1 and RRM1 in tumor tissues can predict the clinical results of patients treated by pemetrexed,DDP,Gemcitabine.


Estimated Enrollment: 300
Study Start Date: November 2009
Estimated Study Completion Date: June 2012
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: cisplatin, dexamethasone,vitamin B12, folic acid
Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
Active Comparator: Group B Drug: cisplatin, gemcitabine
cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Chemotherapy-naive patients with histologically or cytologically confirmed adenocarcinoma and large-cell carcinoma, classified as stage IIIB not amenable to curative treatment or stage IV
  2. With at least one unidimensionally measurable lesion according to the Response Evaluation Criteria in Solid Tumors;
  3. with an Eastern CooperativeOncology Group performance status of 0 or 1,
  4. At least 18 years of age
  5. adequate bone marrow reserve and organ function including calculated creatinine clearance 45 mL/min based on the standard Cockcroft and Gault formula.
  6. Prior radiation therapy was permitted if it was completed at least 4 weeks before study treatment
  7. patients had fully recovered from its acute effects.

Exclusion Criteria:

  1. peripheral neuropathy > National Cancer Institute Common Toxicity Criteria grade 1
  2. progressive brain metastases,
  3. uncontrolled third-space fluid retention before study entry.
  4. Patients unable to interrupt aspirin and other nonsteroidal anti-inflammatory drugs or if they were unable or unwilling to take folic acid, vitamin B12, or corticosteroids.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194453

Locations
China, Guangdong
Cancer Center of Sun Yat-Sen University (CCSU)
Guangzhou, Guangdong, China
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Study Chair: Li Zhang, MD Cancer Center of Sun Yat-Sen University (CCSU)
  More Information

No publications provided by Sun Yat-sen University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Li Zhang, Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT01194453     History of Changes
Other Study ID Numbers: HANSOH20090601
Study First Received: August 25, 2010
Last Updated: February 14, 2012
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Gemcitabine
Pemetrexed
Cisplatin
Dexamethasone
Dexamethasone acetate
 Dexamethasone 21-phosphate
BB 1101
Folic Acid
Vitamin B Complex
Vitamin B 12
Hydroxocobalamin
Vitamins
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents

ClinicalTrials.gov processed this record on May 21, 2013