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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2009 by The First Affiliated Hospital of Guangzhou Medical University
Sponsor:
Information provided by:
The First Affiliated Hospital of Guangzhou Medical University
ClinicalTrials.gov Identifier:
NCT00923637
First received: June 17, 2009
Last updated: NA
Last verified: June 2009
History: No changes posted
  Purpose

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 Intervention Phase
Non Small Cell Lung Cancer
Drug: Pemetrexed/Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by The First Affiliated Hospital of Guangzhou Medical University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: June 2009
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
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)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923637

Contacts
Contact: Jianxing He, MD, FACS +86-20-83337792 drjianxing.he@gmail.com
Contact: Wenlong Shao, MD +86-20-83337792 myfriends2003@126.com

Locations
China, Guangdong
The First Affiliated Hospital of Guangzhou Medical College Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Daoyuan Wang, MD    +86-20-83337792    ghealth2008@gmail.com   
Contact: Wenlong Shao, MD    +86-20-83337792    myfriends2003@126.com   
Principal Investigator: Jianxing He, MD, FACS         
Sponsors and Collaborators
The First Affiliated Hospital of Guangzhou Medical University
Investigators
Principal Investigator: Jianxing He, MD, FACS The First Affiliated Hospital of Guangzhou Medical University
  More Information

Publications:
Responsible Party: Jianxing He, MD, FACS, The First Affiliated Hospital of Guangzhou Medical College
ClinicalTrials.gov Identifier: NCT00923637     History of Changes
Other Study ID Numbers: FAHG20090601A
Study First Received: June 17, 2009
Last Updated: June 17, 2009
Health Authority: China: Food and Drug Administration

Keywords provided by The First Affiliated Hospital of Guangzhou Medical University:
Non small cell lung cancer
video assisted thoracic surgery
Adjuvant chemotherapy
Pemetrexed
Oxaliplatin

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
Oxaliplatin
Pemetrexed
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 14, 2014