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

Sponsor:	Cancer and Leukemia Group B
Collaborator:	National Cancer Institute (NCI)
Information provided by:	Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00077311

Purpose

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.

Condition	Intervention	Phase
Anemia Drug/Agent Toxicity by Tissue/Organ Lung Cancer Neutropenia	Biological: darbepoetin alfa Biological: pegfilgrastim Drug: cisplatin Drug: docetaxel Drug: BNP7787	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: cyclic neutropenia

MedlinePlus related topics: Anemia Cancer Lung Cancer

Drug Information available for: Cisplatin Dimesna Docetaxel Pegfilgrastim Darbepoetin alfa

U.S. FDA Resources

Further study details as provided by Cancer and Leukemia Group B:

Primary Outcome Measures:

Toxicity [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Toxicity profile w/ emphasis on incidence and severity of peripheral neuropathy, febrile neutropenia, and nephrotoxicity

Secondary Outcome Measures:

Response [ Time Frame: during tx,q 3 mon for 1 yr, then q 6 mon for 2 yrs ] [ Designated as safety issue: No ]
Survival [ Time Frame: q 6 mon for 2 yrs after registration, then annually ] [ Designated as safety issue: No ]

Enrollment:	160
Study Start Date:	August 2004
Study Completion Date:	April 2009
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Chemotherapy without BNP7787 Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC	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
Experimental: Chemotherapy + BNP7787 Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787	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

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.

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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00077311

Show 64 Study Locations

Sponsors and Collaborators

Cancer and Leukemia Group B

National Cancer Institute (NCI)

Investigators

Study Chair:

Antonius A. Miller, MD

Comprehensive Cancer Center of Wake Forest University

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

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 with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (CALGB 30303). J Thorac Oncol. 2008 Oct;3(10):1159-65.

Green MR, Miller AA, Wang XF, et al.: Phase II randomized study of dose-dense docetaxel (Doc) and cisplatin (Cis) every two weeks with pegfilgrastim (Pfil) and darbepoetin alfa (Darb) with and without the chemoprotector BNP7787 in patients with advanced non-small cell lung cancer (NSCLC): CAL. [Abstract] J Clin Oncol 25 (Suppl 18): A-7617, 413s, 2007.

Responsible Party:	Monica M Bertagnolli, MD, Cancer and Leukemia Group B
ClinicalTrials.gov Identifier:	NCT00077311 History of Changes
Other Study ID Numbers:	CDR0000350089, U10CA031946, CALGB-30303
Study First Received:	February 10, 2004
Last Updated:	April 6, 2011
Health Authority:	United States: Food and Drug Administration

Keywords provided by Cancer and Leukemia Group B:

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

Additional relevant MeSH terms:

Anemia
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neutropenia
Hematologic Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

Agranulocytosis
Leukopenia
Leukocyte Disorders
Docetaxel
Cisplatin
Darbepoetin alfa
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on February 09, 2012