CompletedPhase 2NCT00077311

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

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.

Checked against the public recordLast updated Jun 30, 2016 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations64
SponsorAlliance for Clinical Trials in Oncology
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Alliance for Clinical Trials in Oncology
Interventions being studied
Biological: darbepoetin alfa; Biological: pegfilgrastim; Drug: cisplatin; Drug: docetaxel; Drug: BNP7787
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • El Camino HospitalMountain View, California
  • Beebe Medical CenterLewes, Delaware
  • CCOP - Christiana Care Health ServicesNewark, Delaware
  • St. Francis HospitalWilmington, Delaware
  • St. Joseph Medical CenterBloomington, Illinois
  • Graham HospitalCanton, Illinois
  • Memorial HospitalCarthage, Illinois
  • University of Illinois Cancer CenterChicago, Illinois
  • Veterans Affairs Medical Center - Chicago Westside HospitalChicago, Illinois
  • University of Chicago Cancer Research CenterChicago, Illinois
  • Louis A. Weiss Memorial HospitalChicago, Illinois
  • Eureka Community HospitalEureka, Illinois

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jun 30, 2016. Always confirm current availability with the study team.

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