Docetaxel Combined With Cisplatin as First Line in Patients With Metastatic Non-small Cell Lung Cancer

NCT01356303 | Suspended Phase 2

• 1 other identifier: RC08/068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This is a phase II, open-label clinical study prospectively enrolling 40 metastatic patients with non small cell lung cancer. The study will enroll patients at King Abdulaziz Medical City, Riyadh. Sub-sites will be open for patient accrual in selected centers in the Kingdom.

Conditions

Non-small Cell Lung Cancer Metastatic

Keywords

Lung cancer

Outcome Measures

Primary Outcomes (1)

• Efficacy

  Efficacy will be measured by calculating the following: * Response rate using Response Evaluation Criteria for Solid Tumor criteria * Time to Disease progression or Death * Overall Survival

  3 years

Secondary Outcomes (1)

• Progression free survival, safety

  3 years

Study Arms (1)

Cisplatin, Docetaxel

EXPERIMENTAL

Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of D5W or NS administered as a 1-hour intravenous infusion, followed by cisplatin at dose of 75 mg/m2administered as a 2-hour intravenous infusion every 3 weeks per cycle for 4-6 cycles

Drug: cisplatin, docetaxel

Interventions

cisplatin, docetaxel DRUG

All patients met the eligibility criteria will undergo treatment with chemotherapy. Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of Dextrose 5% in Water or Normal Saline administered as a 1-hour intravenous infusion followed by cisplatin at dose of 75 mg/m2 administered as a 2-hour intravenous infusion every 3 weeks per cycle for totally 4-6 cycles.

Cisplatin, Docetaxel

Eligibility Criteria

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

You may qualify if:

• Histologically or cytologically proven non-small cell lung carcinoma
• Stage IV metastatic non-small cell lung carcinoma or stage III with malignant pleural effusion.
• Patient should not be eligible for customization chemotherapy (if available at participating institutions).
• Having at least one measurable lesion
• Patient has life expectancy of 12 weeks or greater.
• Age \> 18 years.
• No prior systemic treatment for metastatic lung cancer. Adjuvant treatment given more than 1 year ago is acceptable.
• WHO performance status 0-2 (See Appendix III )
• Adequate organ function:
• Hematology: Neutrophils \> 2 x 10 9 /L, platelets \> 100 x 10 9 /L
• Hepatic function: Total bilirubin \< 1.25 times the upper normal limits, ASAT (SGOT) \< 2 times the upper normal limits
• Renal function: Creatinine \< 1.5 mg/dL; if value is higher than upper normal limit but less than 2 mg/dL, the creatinine clearance should be \> 60min/ml.
• Able to comply with scheduled follow-up and with management of toxicity
• Signed informed consent from patient or legal representative
• Negative urine pregnancy test (if indicated)

You may not qualify if:

• Pregnant or lactating women or women of childbearing potential using inadequate contraception.
• Uncontrolled brain metastatic disease. (CNS disease that is stable \> 4 weeks after radiotherapy in lieu of steroids reduction is eligible).
• Symptomatic peripheral neuropathy \> grade 1 according to the NCI Common Toxicity Criteria Version 3
• Other serious illness or medical condition:
• Unstable cardiac disease requiring treatment
• History of significant neurologic or psychiatric disorders including psychotic disorders, dementia or seizures
• Active uncontrolled infection
• Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening
• Concurrent treatment with any other anti-cancer therapy
• Contraindication of steroid drug administration
• Past (up to 5 years) or concurrent history of other neoplasm except curatively treated non- melanoma skin cancer or in situ carcinoma of the cervix

Sponsors & Collaborators

• National Guard Health Affairs: lead

Study Sites (1)

King Abdul Aziz Medical City for National Guard Health Affairs

Riyadh, 11426, Saudi Arabia

Location

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Abdulrahman Jazieh, MD/MPH

  King Abdul Aziz Medical City for National Guard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2011
• First Posted: May 19, 2011
• Study Start: March 1, 2009
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

SA (1)