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
18 Years
N/A
Both
Anemia, Drug/Agent Toxicity by Tissue/Organ, Lung Cancer, Neutropenia
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 Center | Chicago, Illinois 60637 |
| Duke Comprehensive Cancer Center | Durham, North Carolina 27710 |
| CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
| CCOP - Illinois Oncology Research Association | Peoria, Illinois 61602 |
| Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
| Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University | Columbus, Ohio 43210-1240 |
| Louis A. Weiss Memorial Hospital | Chicago, Illinois 60640 |
| Veterans Affairs Medical Center - Baltimore | Baltimore, Maryland 21201 |
| Veterans Affairs Medical Center - Dallas | Dallas, Texas 75216 |
| SUNY Upstate Medical University Hospital | Syracuse, New York 13210 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| CCOP - Hematology-Oncology Associates of Central New York | East Syracuse, New York 13057 |
| Hematology Oncology Associates of the Quad Cities | Bettendorf, Iowa 52722 |
| Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
| Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
| New Hampshire Oncology-Hematology, PA - Hooksett | Hooksett, New Hampshire 03106 |
| Lenoir Memorial Cancer Center | Kinston, North Carolina 28503-1678 |
| Zimmer Cancer Center at New Hanover Regional Medical Center | Wilmington, North Carolina 28402-9025 |
| University of Illinois Cancer Center | Chicago, Illinois 60612-7243 |
| CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
| Oncology/Hematology Associates of Central Illinois, P.C. | Peoria, Illinois 61602 |
| Parkland Memorial Hospital | Dallas, Texas 75235 |
| Veterans Affairs Medical Center - Chicago Westside Hospital | Chicago, Illinois 60612 |
| University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
| Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees | Camden, New Jersey 08103 |
| Beebe Medical Center | Lewes, Delaware 19958 |
| St. Francis Hospital | Wilmington, Delaware 19805 |
| St. Joseph Medical Center | Bloomington, Illinois 61701 |
| Graham Hospital | Canton, Illinois 61520 |
| Memorial Hospital | Carthage, Illinois 62321 |
| Eureka Community Hospital | Eureka, Illinois 61530 |
| Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
| Galesburg Clinic | Galesburg, Illinois 61401 |
| Mason District Hospital | Havana, Illinois 62644 |
| Hopedale Medical Complex | Hopedale, Illinois 61747 |
| Kewanee Hospital | Kewanee, Illinois 61443 |
| McDonough District Hospital | Macomb, Illinois 61455 |
| BroMenn Regional Medical Center | Normal, Illinois 61761 |
| Community Cancer Center | Normal, Illinois 61761 |
| Community Hospital of Ottawa | Ottawa, Illinois 61350 |
| Cancer Treatment Center at Pekin Hospital | Pekin, Illinois 61554 |
| OSF St. Francis Medical Center | Peoria, Illinois 61637 |
| Proctor Hospital | Peoria, Illinois 61614 |
| Illinois Valley Community Hospital | Peru, Illinois 61354 |
| Perry Memorial Hospital | Princeton, Illinois 61356 |
| St. Margaret's Hospital | Spring Valley, Illinois 61362 |
| Union Hospital Cancer Center at Union Hospital | Elkton MD, Maryland 21921 |
| Creighton University Medical Center | Omaha, Nebraska 68131-2197 |
| Charles R. Wood Cancer Center at Glens Falls Hospital | Glens Falls, New York 12801 |
| Community General Hospital of Greater Syracuse | Syracuse, New York 13215 |
| Oncology Hematology Associates of Central Illinois - Ottawa | Ottawa, Illinois 61350 |
| Missouri Baptist Cancer Center | St. Louis, Missouri 63131 |
| Cancer Resource Center - Lincoln | Lincoln, Nebraska 68510 |
| Cancer Care Associates - Mercy Campus | Oklahoma City, Oklahoma 73120 |
| Methodist Cancer Center at Methodist Hospital - Omaha | Omaha, Nebraska 68114 |
| Zale Lipshy University Hospital | Dallas, Texas 75235-7786 |
| McLeod Regional Medical Center | Florence, South Carolina 29501 |
| Arch Medical Services, Incorporated at Center for Cancer Care Research | Saint Louis, Missouri 63141 |
| Lakes Region General Hospital | Laconia, New Hampshire 03246 |
| Faxton Regional Cancer Center | Utica, New York 13502 |
| El Camino Hospital | Mountain View, California 94040 |
| St. Mary's Regional Cancer Center at St. Mary's Medical Center | Huntington, West Virginia 25702 |
