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

• Status: Suspended
• Trial end date: 2016-08-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Guard Health Affairs
• Treatments: Cisplatin; Docetaxel

Criteria

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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