Completed

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

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What is being tested

darbepoetin alfa

+ pegfilgrastim

+ cisplatin

BiologicalDrug
Who is being recruted

Cytopenia+15

+ Agranulocytosis

+ Bronchial Neoplasms

From 18 to 120 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: August 2004
See protocol details

Summary

Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2004

Actual date on which the first participant was enrolled.

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.

Official TitleA 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 
NCT00077311
Principal SponsorAlliance for Clinical Trials in Oncology
Last updated: January 14, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

160 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 120 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

CytopeniaAgranulocytosisBronchial NeoplasmsCarcinoma, BronchogenicCarcinoma, Non-Small-Cell LungHematologic DiseasesLeukocyte DisordersLeukopeniaLung DiseasesLung NeoplasmsNeoplasmsNeoplasms by SiteNeutropeniaRespiratory Tract DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsChemically-Induced DisordersDrug-Related Side Effects and Adverse Reactions

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Chemotherapy with dose-dense docetaxel and cisplastin with pegfilgrastim and darbepoetin with the addition of BNP7787

Group II

Experimental
Chemotherapy with dose-dense docetaxel and cisplatin with pegfilgrastim and darbepoetin for pts with NSCLC

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 64 locations

Suspended

El Camino Hospital

Mountain View, United StatesSee the location
Suspended

Beebe Medical Center

Lewes, United States
Suspended

CCOP - Christiana Care Health Services

Newark, United States
Suspended

St. Francis Hospital

Wilmington, United States
Completed64 Study Centers