Biweekly Schedule of Docetaxel and Cisplatin in High Risk Patients With Unresectable Non-small Cell Lung Cancer (NSCLC)

NCT00995761 | Completed Phase 2 Results DMC

• 1 other identifier: GNUHIRB-2009-30
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The rationale of phase II study of biweekly docetaxel and cisplatin in patients with unresectable NSCLC are follows: First, the optimal dose and schedule of combination with docetaxel and cisplatin are still controversial (3 weekly versus weekly). Platinum-based combination chemotherapy improves the survival of patients with advanced non-small cell lung cancer (NSCLC) in the first-line setting. Combination chemotherapy with docetaxel and cisplatin is one of the standard platinum-based regimens for treating NSCLC. However, usual standard 3 weekly regimen with docetaxel and cisplatin have consistently produced frequent Grade 3-4 neutropenia, and febrile neutropenia. Although weekly docetaxel and cisplatin is better tolerated than chemotherapy every 3 weeks, especially in the first line setting in terms of myelosuppression, the optimal dose and schedule for administration of the two drugs has not yet been determined. Both 3-weekly docetaxel plus cisplatin and weekly schedule showed similar response rates but had different toxicity profiles. The most frequent grade 3 or 4 toxicities were neutropenia in the 3 weekly schedule and fatigue or asthenia in the weekly schedule. Second, docetaxel and cisplatin have different action and mechanism. Docetaxel showed characteristic early bone marrow suppression 5-7 days after infusion compared with usual 14 days after infusion of cisplatin. Thus, nadir period is not overlapped when the investigators administered both drugs concomittantly. Third, there are many feasible reports of biweekly administration of docetaxel in patients with NSCLC, breast cancer, stomach cancer, and ovarian cancer with better safety profiles. Therefore,the investigators designed this phase II study to evaluate the efficacy and toxicity of biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC and test the hypothesis that biweekly schedule of docetaxel and cisplatin is better tolerated than both standard 3 week and weekly schedule in terms of hematologic (neutropenia) and non-hematologic toxicities (asthenia, interstitial pneumonitis. Additionally the investigators will evaluate polymorphism associated with this study.

Conditions

Non-small Cell Lung Cancer

Keywords

biweekly; docetaxel; cisplatin; non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Response Rates Confirmed With CT or MRI

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. During treatment, a limited history, physical examination, assessment of toxicity, CBC with differentials, and blood chemistry tests were repeated weekly. A chest X-ray was performed every 2 weeks before each cycle. Appropriate imaging studies, including CT scans of the chest and upper abdomen, were performed every two cycles to assess the treatment response, and sooner, if required, to document disease progression. Objective tumor responses were assessed according to the RECIST criteria V 1.0.

  after every 2 cycles of docetaxel and cisplatin

• We Conducted the Present Phase II Study to Investigate the Efficacy and Safety of a Biweekly Schedule of Docetaxel and Cisplatin in Patients With Unresectable NSCLC.

  we conducted the present phase II study to investigate the efficacy and safety of a biweekly schedule of docetaxel and cisplatin in patients with unresectable NSCLC (OS, TTP, and Others)

  after every 2 cycles of docetaxel and cisplatin

Secondary Outcomes (1)

• Time to Progression and Overall Survival Confirmed Through Follow-up and Observation Following Treatment

  From date of enrollment in this study until the date of first documented progression or date of death from any cause, whichever came first, after every 2 cycles of docetaxel and cisplatin

Study Arms (1)

biweekly schedule

NO INTERVENTION

docetaxel 40mg/m2 on day 1,15 every 4weeks cisplatin 40mg/m2 on day 1,15 every 4weeks

Drug: Docetaxel and Cisplatin

Interventions

Docetaxel and Cisplatin DRUG

splitted administration of docetaxel and cisplatin.

Also known as: Docetaxel (Sanofi-Aventis), Cisplatin

biweekly schedule

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 who were≥ 65 years of age and they had an Easten Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, or the patients who were \< 65 years of age and they had an ECOG PS 2
• histologically confirmed non-small cell carcinoma
• stages IIIB-IV disease
• adequate hematologic parameters (hemoglobin concentration of at least 9.0 g/dL, absolute neutrophil count ≥1,500/mm3, and platelet count ≥100,000/mm3), renal function (serum creatinine ≤1.5 mg/dL), and liver function (total bilirubin ≤1.5 mg/dL and serum transaminase level less than twice the upper limit of normal)
• at least one bi-dimensionally measurable lesion, according to the Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1

You may not qualify if:

• Active infection
• Prior chemotherapy, radiotherapy or surgery for their disease,
• A history of myocardial infarction in the last 3 months before entry to the study
• Uncontrolled congestive heart failure or hypertension
• Uncontrolled diabetes mellitus, pregnancy, lactation or a prior second primary cancer except for cervix cancer in situ or skin cancer
• All the patients provided written informed consent before they entered the study

Sponsors & Collaborators

• Gyeongsang National University Hospital: lead

Study Sites (1)

Gyeongsang National University Hospital

Jinju, Gyeongsang-Nam-Do, 660-702, South Korea

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; Cisplatin

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)

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

Limitations and Caveats

completed without a major limitation

Results Point of Contact

• Title: Gyeong-Won Lee M.D.Ph.D.
• Organization: Gyeongsang National University Hospital

brightree@lycos.co.kr

82-55-750-8066

Study Officials

• Gyeong-Won Lee, M.D.Ph.D.

  Gyeongsang National University Hospital IRB

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: March 3, 2014
• Results First Posted: March 3, 2014

Record last verified: 2014-02

Locations

KR (1)