Pemetrexed Plus Oxaliplatin as Adjuvant Chemotherapy for Radically Resected Non-Small Cell Lung Cancer
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ClinicalTrials.gov 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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer | Drug: Pemetrexed/Oxaliplatin | Phase 2 |

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 |

- 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)
- 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 ]
- 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 ]

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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.
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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.

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 ClinicalTrials.gov identifier (NCT number): NCT00923637
Contact: Jianxing He, MD, FACS | +86-20-83337792 | drjianxing.he@gmail.com | |
Contact: Wenlong Shao, MD | +86-20-83337792 | myfriends2003@126.com |
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 |
Principal Investigator: | Jianxing He, MD, FACS | The First Affiliated Hospital of Guangzhou Medical University |
Responsible Party: | Jianxing He, MD, FACS, The First Affiliated Hospital of Guangzhou Medical College |
ClinicalTrials.gov 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 |
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