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

Phase 2

Completed

• Conditions: Anemia; Drug/Agent Toxicity by Tissue/Organ; Lung Cancer; Neutropenia
• Interventions: Biological: darbepoetin alfa; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Drug: BNP7787

• Registration Number: NCT00077311
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief 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.

Study Timeline

• Study First Submitted: 2004-02-10
• Study First Submitted QC: 2004-02-11
• Study First Posted: 2004-02-12
• Study Start: 2004-08
• Primary Completion: 2006-07
• Study Completion: 2009-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-28
• Last Update Posted: 2016-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chemotherapy without BNP7787	docetaxel	Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Chemotherapy + BNP7787	BNP7787	Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Chemotherapy + BNP7787	darbepoetin alfa	Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Chemotherapy + BNP7787	pegfilgrastim	Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Chemotherapy + BNP7787	cisplatin	Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Chemotherapy without BNP7787	darbepoetin alfa	Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Chemotherapy without BNP7787	pegfilgrastim	Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC
Chemotherapy + BNP7787	docetaxel	Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787
Chemotherapy without BNP7787	cisplatin	Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC

Primary Outcome Measures

Name	Time	Method
Toxicity	12 weeks	Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity

Secondary Outcome Measures

Name	Time	Method
Survival	q 6 mon for 2 yrs after registration, then annually
Response	during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs

Trial Locations

Locations (64)

El Camino Hospital; 🇺🇸 Mountain View, California, United States

Beebe Medical Center; 🇺🇸 Lewes, Delaware, United States

CCOP - Christiana Care Health Services; 🇺🇸 Newark, Delaware, United States

St. Francis Hospital; 🇺🇸 Wilmington, Delaware, United States

St. Joseph Medical Center; 🇺🇸 Bloomington, Illinois, United States

Graham Hospital; 🇺🇸 Canton, Illinois, United States

Memorial Hospital; 🇺🇸 Carthage, Illinois, United States

University of Illinois Cancer Center; 🇺🇸 Chicago, Illinois, United States

Veterans Affairs Medical Center - Chicago Westside Hospital; 🇺🇸 Chicago, Illinois, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States

Scroll for more (54 remaining)