NCT00077311

Docetaxel and Cisplatin With or Without Dimesna in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

A Phase II Randomized Study Of Dose-Dense Docetaxel And Cisplatin Every Two Weeks With Pegfilgrastim And Darbepoetin Alfa With And Without The Chemoprotector BNP7787 In Patients With Advanced Non-Small Cell Lung Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Alliance for Clinical Trials in Oncology · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as dimesna, may help prevent or decrease the side effects (such as nerve, kidney, and inner ear damage) caused by chemotherapy. PURPOSE: This randomized phase II trial is studying giving docetaxel and cisplatin together with dimesna to see how well it works compared to giving docetaxel and cisplatin alone in treating patients with stage IIIB or stage IV non-small cell lung cancer.

Detailed description

OBJECTIVES: Primary * Compare the incidence and severity of peripheral neuropathy in patients with stage IIIB or IV non-small cell lung cancer treated with docetaxel and cisplatin with or without dimesna. * Compare the feasibility of these regimens, in terms of febrile neutropenia and treatment delays, in these patients. * Compare the objective response rate in patients treated with these regimens. Secondary * Compare the survival and failure-free survival of patients treated with these regimens. * Compare the toxicity profile of these regimens in these patients. * Compare the incidence and severity of cisplatin-induced nephrotoxicity in patients treated with these regimens. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. * Arm I\*: Patients receive docetaxel IV over 1 hour and cisplatin IV over 1 hour on day 1 and pegfilgrastim subcutaneously (SC) on day 2. * Arm II\*: Patients receive docetaxel, cisplatin, and pegfilgrastim as in arm I and dimesna IV over 30 minutes on day 1. NOTE: \*In both arms, darbepoetin alfa is administered SC on day 1 of each course for hemoglobin ≤ 11 g/dL. In both arms, treatment repeats every 2 weeks for a total of 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 1 year and then every 6 months for 2 years.

Conditions

• Anemia
• Drug/Agent Toxicity by Tissue/Organ
• Lung Cancer
• Neutropenia

Interventions

Type	Name	Description
BIOLOGICAL	darbepoetin alfa	200 mcg sub Q on day 1 of each cycle if HgB \< or = 11 g/dL
BIOLOGICAL	pegfilgrastim	6 mg sub Q day 2 of each cycle
DRUG	cisplatin	75 mg/sq m IV over 1 hr Day 1 of each cycle
DRUG	docetaxel	75 mg/sq m IV over 1 hr Day 1 of each cycle
DRUG	BNP7787	40 g IV over 30 min Day 1 of each cycle

Timeline

• Start date: 2004-08-01
• Primary completion: 2006-07-01
• Completion: 2009-04-01
• First posted: 2004-02-12
• Last updated: 2016-06-30

Locations

64 sites across 1 country: United States