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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Anemia, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Neutropenia

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Trial Information

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


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.

PROJECTED ACCRUAL: A total of 152 patients (76 per treatment arm) will be accrued for this
study within 18-20 months.

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Toxicity

Outcome Description:

Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity

Outcome Time Frame:

12 weeks

Safety Issue:

Yes

Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000350089

NCT ID:

NCT00077311

Start Date:

August 2004

Completion Date:

April 2009

Related Keywords:

  • Anemia
  • Drug/Agent Toxicity by Tissue/Organ
  • Lung Cancer
  • Neutropenia
  • drug/agent toxicity by tissue/organ
  • anemia
  • neutropenia
  • stage IV non-small cell lung cancer
  • stage IIIB non-small cell lung cancer
  • recurrent non-small cell lung cancer
  • squamous cell lung cancer
  • large cell lung cancer
  • adenocarcinoma of the lung
  • bronchoalveolar cell lung cancer
  • adenosquamous cell lung cancer
  • Anemia
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Neutropenia

Name

Location

University of Chicago Cancer Research CenterChicago, Illinois  60637
Duke Comprehensive Cancer CenterDurham, North Carolina  27710
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Elliot Regional Cancer CenterManchester, New Hampshire  03103
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Louis A. Weiss Memorial HospitalChicago, Illinois  60640
Veterans Affairs Medical Center - BaltimoreBaltimore, Maryland  21201
Veterans Affairs Medical Center - DallasDallas, Texas  75216
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
CCOP - Hematology-Oncology Associates of Central New YorkEast Syracuse, New York  13057
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Greenebaum Cancer Center at University of Maryland Medical CenterBaltimore, Maryland  21201
New Hampshire Oncology-Hematology, PA - HooksettHooksett, New Hampshire  03106
Lenoir Memorial Cancer CenterKinston, North Carolina  28503-1678
Zimmer Cancer Center at New Hanover Regional Medical CenterWilmington, North Carolina  28402-9025
University of Illinois Cancer CenterChicago, Illinois  60612-7243
CCOP - Nevada Cancer Research FoundationLas Vegas, Nevada  89109-2306
Oncology/Hematology Associates of Central Illinois, P.C.Peoria, Illinois  61602
Parkland Memorial HospitalDallas, Texas  75235
Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois  60612
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Cancer Institute of New Jersey at the Cooper University Hospital - VoorheesCamden, New Jersey  08103
Beebe Medical CenterLewes, Delaware  19958
St. Francis HospitalWilmington, Delaware  19805
St. Joseph Medical CenterBloomington, Illinois  61701
Graham HospitalCanton, Illinois  61520
Memorial HospitalCarthage, Illinois  62321
Eureka Community HospitalEureka, Illinois  61530
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Hopedale Medical ComplexHopedale, Illinois  61747
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Community Cancer CenterNormal, Illinois  61761
Community Hospital of OttawaOttawa, Illinois  61350
Cancer Treatment Center at Pekin HospitalPekin, Illinois  61554
OSF St. Francis Medical CenterPeoria, Illinois  61637
Proctor HospitalPeoria, Illinois  61614
Illinois Valley Community HospitalPeru, Illinois  61354
Perry Memorial HospitalPrinceton, Illinois  61356
St. Margaret's HospitalSpring Valley, Illinois  61362
Union Hospital Cancer Center at Union HospitalElkton MD, Maryland  21921
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Charles R. Wood Cancer Center at Glens Falls HospitalGlens Falls, New York  12801
Community General Hospital of Greater SyracuseSyracuse, New York  13215
Oncology Hematology Associates of Central Illinois - OttawaOttawa, Illinois  61350
Missouri Baptist Cancer CenterSt. Louis, Missouri  63131
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Cancer Care Associates - Mercy CampusOklahoma City, Oklahoma  73120
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Zale Lipshy University HospitalDallas, Texas  75235-7786
McLeod Regional Medical CenterFlorence, South Carolina  29501
Arch Medical Services, Incorporated at Center for Cancer Care ResearchSaint Louis, Missouri  63141
Lakes Region General HospitalLaconia, New Hampshire  03246
Faxton Regional Cancer CenterUtica, New York  13502
El Camino HospitalMountain View, California  94040
St. Mary's Regional Cancer Center at St. Mary's Medical CenterHuntington, West Virginia  25702