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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00077311
• Other study ID #: CALGB-30303
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2004
• Last updated: June 28, 2016
• Start date: August 2004
• Est. completion date: April 2009

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: April 2009
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed* non-small cell lung cancer of 1 of the following subtypes:

• Squamous carcinoma

• Basaloid carcinoma

• Adenocarcinoma

• Bronchoalveolar carcinoma

• Adenosquamous carcinoma

• Large cell carcinoma

• Large cell neuroendocrine carcinoma

• Giant cell carcinoma

• Sarcomatoid carcinoma

• Non-small cell carcinoma not otherwise specified NOTE: *Histologic or cytologic confirmation of recurrence is required for patients who have undergone prior complete resection

• Stage IIIB disease due to malignant pleural effusion OR stage IV disease

• Measurable disease

• At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan

• The following are considered nonmeasurable disease:

• Bone lesions

• Brain metastases or leptomeningeal disease

• Ascites

• Pleural/pericardial effusion

• Abdominal masses not confirmed and followed by imaging techniques

• Cystic lesions

• Tumor lesions situated in a previously irradiated area

• Brain metastases are allowed provided patient is neurologically stable and off steroids

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• Not specified

Hematopoietic

• Granulocyte count = 1,500/mm^3

• Platelet count = 100,000/mm^3

Hepatic

• Bilirubin = 1.5 mg/dL

• AST = 1.5 times upper limit of normal (ULN)

• Alkaline phosphatase = 2.5 times ULN

Renal

• Creatinine = ULN

Other

• Not pregnant or nursing

• Fertile patients must use effective contraception

• No grade 2 or greater neuropathy

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No other concurrent growth factors

Chemotherapy

• No prior chemotherapy

• No other concurrent chemotherapy

Endocrine therapy

• See Disease Characteristics

• No concurrent hormonal therapy except steroids administered for adrenal failure, hormones for non-cancer-related conditions (e.g., insulin for diabetes), or intermittent dexamethasone as an antiemetic

Radiotherapy

• See Disease Characteristics

• Prior radiotherapy allowed for brain metastases only

• No concurrent palliative radiotherapy

Surgery

• See Disease Characteristics

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Carcinoma, Non-Small-Cell Lung
• Drug/Agent Toxicity by Tissue/Organ
• Lung Cancer
• Lung Neoplasms
• Neutropenia

Intervention

Biological:
• darbepoetin alfa
200 mcg sub Q on day 1 of each cycle if HgB < or = 11 g/dL
• 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
• docetaxel
75 mg/sq m IV over 1 hr Day 1 of each cycle
• BNP7787
40 g IV over 30 min Day 1 of each cycle

Locations

Country	Name	City	State
United States	Greenebaum Cancer Center at University of Maryland Medical Center	Baltimore	Maryland
United States	Veterans Affairs Medical Center - Baltimore	Baltimore	Maryland
United States	Hematology Oncology Associates of the Quad Cities	Bettendorf	Iowa
United States	St. Joseph Medical Center	Bloomington	Illinois
United States	Graham Hospital	Canton	Illinois
United States	Memorial Hospital	Carthage	Illinois
United States	Louis A. Weiss Memorial Hospital	Chicago	Illinois
United States	University of Chicago Cancer Research Center	Chicago	Illinois
United States	University of Illinois Cancer Center	Chicago	Illinois
United States	Veterans Affairs Medical Center - Chicago Westside Hospital	Chicago	Illinois
United States	Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University	Columbus	Ohio
United States	Parkland Memorial Hospital	Dallas	Texas
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	Veterans Affairs Medical Center - Dallas	Dallas	Texas
United States	Zale Lipshy University Hospital	Dallas	Texas
United States	Duke Comprehensive Cancer Center	Durham	North Carolina
United States	Union Hospital Cancer Center at Union Hospital	Elkton MD	Maryland
United States	Eureka Community Hospital	Eureka	Illinois
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Galesburg Clinic	Galesburg	Illinois
United States	Galesburg Cottage Hospital	Galesburg	Illinois
United States	Charles R. Wood Cancer Center at Glens Falls Hospital	Glens Falls	New York
United States	Wayne Memorial Hospital, Incorporated	Goldsboro	North Carolina
United States	Mason District Hospital	Havana	Illinois
United States	New Hampshire Oncology-Hematology, PA - Hooksett	Hooksett	New Hampshire
United States	Hopedale Medical Complex	Hopedale	Illinois
United States	St. Mary's Regional Cancer Center at St. Mary's Medical Center	Huntington	West Virginia
United States	Holden Comprehensive Cancer Center at University of Iowa	Iowa City	Iowa
United States	Kewanee Hospital	Kewanee	Illinois
United States	Lenoir Memorial Cancer Center	Kinston	North Carolina
United States	Lakes Region General Hospital	Laconia	New Hampshire
United States	CCOP - Nevada Cancer Research Foundation	Las Vegas	Nevada
United States	University Medical Center of Southern Nevada	Las Vegas	Nevada
United States	Beebe Medical Center	Lewes	Delaware
United States	Cancer Resource Center - Lincoln	Lincoln	Nebraska
United States	McDonough District Hospital	Macomb	Illinois
United States	Elliot Regional Cancer Center	Manchester	New Hampshire
United States	El Camino Hospital	Mountain View	California
United States	CCOP - Christiana Care Health Services	Newark	Delaware
United States	BroMenn Regional Medical Center	Normal	Illinois
United States	Community Cancer Center	Normal	Illinois
United States	Cancer Care Associates - Mercy Campus	Oklahoma City	Oklahoma
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Methodist Cancer Center at Methodist Hospital - Omaha	Omaha	Nebraska
United States	Community Hospital of Ottawa	Ottawa	Illinois
United States	Oncology Hematology Associates of Central Illinois - Ottawa	Ottawa	Illinois
United States	Cancer Treatment Center at Pekin Hospital	Pekin	Illinois
United States	CCOP - Illinois Oncology Research Association	Peoria	Illinois
United States	Methodist Medical Center of Illinois	Peoria	Illinois
United States	Oncology/Hematology Associates of Central Illinois, P.C.	Peoria	Illinois
United States	OSF St. Francis Medical Center	Peoria	Illinois
United States	Proctor Hospital	Peoria	Illinois
United States	Illinois Valley Community Hospital	Peru	Illinois
United States	Perry Memorial Hospital	Princeton	Illinois
United States	Arch Medical Services, Incorporated at Center for Cancer Care Research	Saint Louis	Missouri
United States	St. Margaret's Hospital	Spring Valley	Illinois
United States	Missouri Baptist Cancer Center	St. Louis	Missouri
United States	CCOP - Hematology-Oncology Associates of Central New York	Syracuse	New York
United States	Community General Hospital of Greater Syracuse	Syracuse	New York
United States	SUNY Upstate Medical University Hospital	Syracuse	New York
United States	Faxton Regional Cancer Center	Utica	New York
United States	Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees	Voorhees	New Jersey
United States	St. Francis Hospital	Wilmington	Delaware
United States	Zimmer Cancer Center at New Hanover Regional Medical Center	Wilmington	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Miller AA, Wang XF, Gu L, Hoffman P, Khatri J, Dunphy F, Edelman MJ, Bolger M, Vokes EE, Green MR; Cancer and Leukemia Group B (CALGB). Phase II randomized study of dose-dense docetaxel and cisplatin every 2 weeks with pegfilgrastim and darbepoetin alfa w — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity	12 weeks	Yes
Secondary	Response		during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs	No
Secondary	Survival		q 6 mon for 2 yrs after registration, then annually	No