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

NCT00923637 | Unknown Phase 2 DMC

• 1 other identifier: FAHG20090601A
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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).

Conditions

Non Small Cell Lung Cancer

Keywords

Non small cell lung cancer; video assisted thoracic surgery; Adjuvant chemotherapy; Pemetrexed; Oxaliplatin

Outcome Measures

Primary Outcomes (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.

  Every 21 days

Secondary Outcomes (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.

  Every 3 months

Interventions

Pemetrexed/Oxaliplatin DRUG

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.

Also known as: Pemtrexed (Alimta), Oxaliplatin (Eloxatin)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Guangzhou Medical University: lead

Study Sites (1)

The First Affiliated Hospital of Guangzhou Medical College

Guangzhou, Guangdong, 510120, China

RECRUITING

Related Publications (1)

• Li SB, He JX, Chen HZ, Ge LH, Wei B, Yin WQ, Cheng XY, Liu J, Xu X. [Injection of activated carbon nanoparticles for guiding lymphadenectomy during minimal invasive surgery in lung cancer]. Zhonghua Zhong Liu Za Zhi. 2008 Mar;30(3):228-30. Chinese.

  PMID: 18756943 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Pemetrexed; Oxaliplatin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

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; Coordination Complexes; Organic Chemicals

Study Officials

• Jianxing He, MD, FACS

  The First Affiliated Hospital of Guangzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jianxing He, MD, FACS

CONTACT

+86-20-83337792; drjianxing.he@gmail.com

Wenlong Shao, MD

CONTACT

+86-20-83337792; myfriends2003@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 18, 2009

Record last verified: 2009-06

Locations

CN (1)