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TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

Information source: Chonnam National University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Carcinoma, Non Small Cell Lung

Intervention: Taxotere (Drug); Pemetrexed (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Chonnam National University Hospital

Official(s) and/or principal investigator(s):
Young-Chul Kim, MD, PhD, Study Chair, Affiliation: Chonnam National University Hospital

Summary

This study is:

- A multicenter, prospective, randomized, phase 3 trial.

- To prove non-inferiority of Taxotere/Cisplatin compared to Pemetrexed/Cisplatin as a

front line treatment of patients with non-squamous cell lung cancer.

- 276 patients will be recruited.

Clinical Details

Official title: A Randomized Phase III Study of TaxoteRe Plus Cisplatin Versus AlImta Plus Cisplatin in 1st Line Non-squamous Cell Type Lung Cancer

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Progression Free Survival

Secondary outcome:

Overall Survival (months from the beginning of first cycle chemotherapy)

Safety Profile

Response rate

Detailed description: Docetaxel is being used in 60mg/m2 3 weekly dosage in Japan and several east Asian institutions. Docetaxel 60mg/m2 and Cisplatin 70 mg/m3 3 weekly regimen will be compared to Pemetrexed 500mg/m2 and Cisplatin 70 mg/m2 3 weekly regimen in first line NSCLC with non-squamous histology.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Age >= 18 years old

- ECOG performance status 0-2

- Non-squamous cell type non-small cell lung cancer (NSCLC)

- Stage IV, Stage IIIB cannot be treated with curative intent or Relapsed after surgery

or radiation therapy

- No prior chemotherapy except adjuvant chemotherapy and concurrent chemoradiation

treatment. The last dose of adjuvant chemotherapy should be at least 6 months earlier from randomization, and the regimen should not contain docetaxel or pemetrexed.

- No prior immunotherapy, biologic therapy

- Measurable lesion with Response Evaluation Criteria in Solid Tumors (RECIST) version

1. 1

- Hemoglobin >=9. 0g/dl, Platelet >=100,000/uL, neutrophil >=1,500 /uL Creatinine <=1. 5

x upper normal limit or creatinine clearance >=60 mL/min Bilirubin <=1. 5 x upper normal limit, Transaminases <=2 x upper normal limit Alkaline phosphatase <=2 x upper normal limit

- Written informed consent

Exclusion Criteria:

- Pregnancy, Lactating woman

- Woman in child bearing age who refuses to do pregnancy test

- Moderate or greater than grade 1 motor or sensory neurotoxicity

- Hypersensitivity to taxane

- Comorbidity or poor medical conditions

- Other malignancy (except cured basal cell carcinoma or uterine cervical carcinoma in

situ)

- Concurrent treatment with other investigational drugs within 30 days before

randomization

- Active treatment with other anticancer chemotherapy

- EGFR mutation (exon 19 deletion, L858R, L861Q, G719A/C/S)

Locations and Contacts

Hallym University Medical Center, Anyang, Korea, Republic of

Dankook University Hospital, Cheonan 330-715, Korea, Republic of

Keimyung University Dongsan Center, Daegu 700-712, Korea, Republic of

Yeungnam Univeristy Hospital, Daegu, Korea, Republic of

Chosun University Hospital, Gwangju, Korea, Republic of

Wonkwang University Hospital, Iksan, Korea, Republic of

Inha University Hospital, Incheon, Korea, Republic of

Kosin University Gospel Hospital, Pusan, Korea, Republic of

Pusan National University Hospital, Pusan 602-739, Korea, Republic of

Konkuk university medical center, Seoul 143-729, Korea, Republic of

Korea Cancer Center Hospital, Seoul, Korea, Republic of

Korea University Medical Center, Seoul, Korea, Republic of

Wonju Christian Hospital, Wonju, Korea, Republic of

Chonnam National University Hwasun Hospital, Hwasun, Jeonnam 519-709, Korea, Republic of

Kyungpook National University Medical Center, Daegu, Kyungpook, Korea, Republic of

Additional Information

Starting date: July 2011
Last updated: July 13, 2015

Page last updated: August 23, 2015

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