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Pemetrexed Plus Oxaliplatin as Adjuvant Chemotherapy for Radically Resected Non-Small Cell Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00923637
Recruitment Status : Unknown
Verified June 2009 by The First Affiliated Hospital of Guangzhou Medical University.
Recruitment status was:  Recruiting
First Posted : June 18, 2009
Last Update Posted : June 18, 2009
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University

Brief Summary:
The main purpose of this phase II trial is to evaluate the clinical feasibility-in terms of patients without dose limiting toxicities or premature treatment withdrawal or death-of administering adjuvant chemotherapy of pemetrexed followed by pemetrexed/oxaliplatin immediately post-video-assisted thoracic surgery (VATS) in patients with completely resected Non-Small Cell Lung Cancer (NSCLC).

Condition or disease Intervention/treatment Phase
Non Small Cell Lung Cancer Drug: Pemetrexed/Oxaliplatin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility of Administering Adjuvant Chemotherapy of Pemetrexed Followed by Pemetrexed/Oxaliplatin Immediately Post-VATS in Patients With Completely Resected NSCLC
Study Start Date : June 2009
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Intervention Details:
  • Drug: Pemetrexed/Oxaliplatin
    In the first cycle, patients received Pemetrexed 500 mg/m2 (i.v. infusion over 10 minutes) on day 1 of a 21-day cycle. From 2nd cycle, patients received pemetrexed 500 mg/m2 (i.v. infusion over 10 minutes) then oxaliplatin 120 mg/m2 (i.v. infusion over 120 minutes) on day 1 of a 21-day cycle. Study drug administration is to begin on d14 to d28 after R0 resection of the tumor. A total of three cycles is intended for patients with stage IB NSCLC, and four cycles for II-IIIA NSCLC, respectively.
    Other Names:
    • Pemtrexed (Alimta)
    • Oxaliplatin (Eloxatin)

Primary Outcome Measures :
  1. To determine the clinical feasibility rate (CFR) of 4 cycles of adjuvant chemotherapy with pemetrexed followed by pemetrexed/oxaliplatin in patients with NSCLC stage IB, IIA, IIB and IIIA after a postsurgical interval of 2-4 weeks. [ Time Frame: Every 21 days ]

Secondary Outcome Measures :
  1. To determine the time to treatment failure, the relapse free survival, the overall survival, the distant metastases free survival, local relapse free survival, the localization of relapse. [ Time Frame: Every 3 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with completely resected stage IB (> 4 cm), II, or IIIA non-squamous NSCLC by VATS. Patient must be enrolled and begin therapy within 4 weeks from the date of complete surgical resection.
  • Fresh tissue must be available for genomics expression profiling.
  • ECOG performance status of 0 or 1.
  • No prior chemotherapy, radiation therapy, or biologic/targeted therapy within the last 5 years. Prior therapy with low dose methotrexate or similar medications is allowed if therapy used to treat non-malignant conditions.
  • Age ≥ 18 years.
  • No previous or concomitant malignancy in the past 5 years other than curatively-treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin.
  • No other serious medical or psychiatric illness.
  • Signed informed consent.
  • Required laboratory data within one week of enrollment:

    • ANC or AGC ≥ 1500 per uL;
    • Platelets ≥ 100,000 per uL;
    • Total bilirubin ≤ 1.5 mg/dL;
    • Creatinine < 2 mg/dL, creatinine clearance ≥ 45 mL/min;
    • SGOT/SGPT ≤ 1.5× ULN.
  • Females of child-bearing potential (not surgically sterilized and between menarche and 1 year post menopause) must test negative for pregnancy within 7 days prior to or at the time of enrollment based on a serum pregnancy test.
  • Both sexually active males and females of reproductive potential must agree to use a reliable method of birth control, as determined by the patient and their health care team, during the study and for 3 months following the last dose of study drug.

Exclusion Criteria:

  • Treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
  • Concurrent administration of any other anti-tumor therapy.
  • Inability to comply with protocol or study procedures.
  • Active infection requiring IV antibiotics, antifungal or antiviral agents, that in the opinion of the investigator would compromise the patient's ability to tolerate therapy.
  • Major surgery (other than definitive lung cancer surgery) within two weeks of study or other serious concomitant systemic disorders that, in the opinion of the investigator, would compromise the safety of the patient or compromise the patient's ability to complete the study.
  • Myocardial infarction having occurred less than 6 months before inclusion, any known uncontrolled arrhythmia, symptomatic angina pectoris, active ischemia, or cardiac failure not controlled by medications.
  • Contraindication to corticosteroids.
  • Inability or unwillingness to take folic acid or vitamin B12 supplementation.
  • Unwillingness to stop taking herbal supplements while on study.
  • Presence of clinically significant third-space fluid collections (for example, ascites or pleural effusions) that cannot be controlled by drainage or other procedures prior to study entry and throughout study enrollment as the distribution of pemetrexed in this fluid space is not fully understood.
  • Inability to discontinue administration of aspirin at a dose > 1300 mg/day or other long acting, non-steroidal anti-inflammatory agents for 2 days before, the day of, and 2 days after the dose of pemetrexed (5 days prior for long-acting agents such as piroxicam). Moderate dose ibuprofen may be continued.
  • Female patients that are pregnant or breast-feeding.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00923637

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Contact: Jianxing He, MD, FACS +86-20-83337792
Contact: Wenlong Shao, MD +86-20-83337792

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China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Daoyuan Wang, MD    +86-20-83337792   
Contact: Wenlong Shao, MD    +86-20-83337792   
Principal Investigator: Jianxing He, MD, FACS         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
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Principal Investigator: Jianxing He, MD, FACS The First Affiliated Hospital of Guangzhou Medical University
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Responsible Party: Jianxing He, MD, FACS, The First Affiliated Hospital of Guangzhou Medical College Identifier: NCT00923637    
Other Study ID Numbers: FAHG20090601A
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: June 18, 2009
Last Verified: June 2009
Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
Non small cell lung cancer
video assisted thoracic surgery
Adjuvant chemotherapy
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors