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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
Not Enrolling
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



- 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

- 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.


- 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


- 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



- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified


- Granulocyte count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3


- Bilirubin ≤ 1.5 mg/dL

- AST ≤ 1.5 times upper limit of normal (ULN)

- Alkaline phosphatase ≤ 2.5 times ULN


- Creatinine ≤ ULN


- Not pregnant or nursing

- Fertile patients must use effective contraception

- No grade 2 or greater neuropathy


Biologic therapy

- No other concurrent growth factors


- 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


- See Disease Characteristics

- Prior radiotherapy allowed for brain metastases only

- No concurrent palliative radiotherapy


- See Disease Characteristics

Type of Study:


Study Design:

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

Outcome Measure:


Outcome Description:

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

Outcome Time Frame:

12 weeks

Safety Issue:


Principal Investigator

Antonius A. Miller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University


United States: Food and Drug Administration

Study ID:




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



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