Influence of Prior Chemotherapy on Clinical Benefit With Erlotinib in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer With or Without EGFR Gene Mutation

NCT01204307 | Completed Phase 2 DMC

• 1 other identifier: 99-1896C
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 4

Brief Summary

To compare the differential influence of 1st line doublet chemotherapy containing Docetaxel versus Pemetrexed on clinical efficacy of Erlotinib as a second line therapy in patients with relapsed or progressed non-squamous NSCLC.

Conditions

Advanced Non-Squamous Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Response rate to erlotinib with Docetaxel/cisplatin or Pemetrexed/cisplatin

  Eligible patients will be randomized to receive 1st line chemotherapy with either Docetaxel (60mg/m2)/Cisplatin (75mg/m2) or Pemetrexed (500mg/m2)/Cisplatin (75mg/m2) for 4-6 cycles. Patients will be followed up without any maintenance treatment after 4-6 cycles of chemotherapy. Once patients are found tumor relapse or in progression, all the patients will be prescribed Erlotinib 150 mg/day until disease progression, unacceptable toxicity or death. Patients will be followed up every 2-3 months for their responsive rate.

  2-3 months

Secondary Outcomes (1)

• Progression-free survival and overall survival after erlotinib treatment with 1st line Docetaxel/cisplatin or Pemetrexed/cisplatin.

  12-24 months

Study Arms (2)

docetaxel/cisplatin

EXPERIMENTAL

The treatment schedule comprises a maximum of six 3-week treatment cycles consisting of weekly docetaxel (30 mg/m2) and cisplatin (37.5 mg/m2) for 2 consecutive weeks followed by a 1-week treatment-free period. The patients will be assessed after each cycle and a final assessment will be done after three and six cycles.

Drug: Docetaxel/cisplatin

Pemetrexed/cisplatin

ACTIVE COMPARATOR

The patients are given pemetrexed (500 mg/m2 as a 10-min intravenous infusion) and cisplatin (75 mg/m2) on day 1 every 21 days. Dexamethasone (4 mg) is administered twice daily on the day before, the day of, and the day after each dose of pemetrexed. Oral folic acid supplementation (1000 mg) is administered daily, beginning approximately 2 weeks prior to the first dose of pemetrexed and continues until 3 weeks after treatment discontinuation. A 1000 mg vitamin B12 injection is administered intramuscularly approximately 1-2 weeks before the first dose of pemetrexed and is repeated approximately every 9 weeks until 3 weeks after therapy discontinuation.

Drug: Pemetrexed/cisplatin

Interventions

Docetaxel/cisplatin DRUG

The treatment schedule comprises a maximum of six 3-week treatment cycles consisting of weekly docetaxel (30 mg/m2) and cisplatin (37.5 mg/m2) for 2 consecutive weeks followed by a 1-week treatment-free period. The patients will be assessed after each cycle and a final assessment will be done after three and six cycles.

Also known as: Taxotere- made by Sanofi-Aventis.

docetaxel/cisplatin

Pemetrexed/cisplatin DRUG

The patients are given pemetrexed (500 mg/m2 as a 10-min intravenous infusion) and cisplatin (75 mg/m2) on day 1 every 21 days. Dexamethasone (4 mg) is administered twice daily on the day before, the day of, and the day after each dose of pemetrexed. Oral folic acid supplementation (1000 mg) is administered daily, beginning approximately 2 weeks prior to the first dose of pemetrexed and continues until 3 weeks after treatment discontinuation. A 1000 mg vitamin B12 injection is administered intramuscularly approximately 1-2 weeks before the first dose of pemetrexed and is repeated approximately every 9 weeks until 3 weeks after therapy discontinuation.

Also known as: Alimta- made by LiLy.

Pemetrexed/cisplatin

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients \> 18 years, \<75 years old
• Pathological confirmation of non-squamous NSCLC
• Clinical stage IIIB or IV
• Measurable tumor size by RECIST criteria
• ECOG \<2
• Adequate hematological laboratory parameters
• Adequate hepatic, renal laboratory parameters

You may not qualify if:

• Un-specified NSCLC
• Prior therapy with any chemotherapy or EGFR TKI or monoclonal antibodies
• Any unstable systemic disease (active infection, hypertension, unstable angina, CHF, liver cirrhosis, end stage renal failure etc., )
• Nursing or pregnant mothers
• Untreated Brain metastasis
• ECOG\>2

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead
• Taiwan Chest Disease Association: collaborator

Study Sites (4)

Chang Gung Memorial Hospital

Taipei, Taipei, 10507, Taiwan

Location

Chang Gung Memorial Hospital, Kaohsiung Branch

Kaohsiung City, Taiwan

Location

McKay Memorial Hospital

Taipei, Taiwan

Location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taiwan

Location

Related Publications (1)

• Feng PH, Lee KY, Chang YL, Chan YF, Kuo LW, Lin TY, Chung FT, Kuo CS, Yu CT, Lin SM, Wang CH, Chou CL, Huang CD, Kuo HP. CD14(+)S100A9(+) monocytic myeloid-derived suppressor cells and their clinical relevance in non-small cell lung cancer. Am J Respir Crit Care Med. 2012 Nov 15;186(10):1025-36. doi: 10.1164/rccm.201204-0636OC. Epub 2012 Sep 6.

  PMID: 22955317 DERIVED

MeSH Terms

Interventions

Docetaxel; Cisplatin; Pemetrexed

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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

Study Officials

• Han-Pin Kuo, MD, PhD

  Taiwan Chest Disease Association and Chang Gung Memorial Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: September 16, 2010
• First Posted: September 17, 2010
• Study Start: January 1, 2010
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: July 28, 2015

Record last verified: 2010-09

Locations

TW (4)