CompletedPhase 2NCT00281970

Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

RATIONALE: Drugs used in chemotherapy, such as docetaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. PURPOSE: This phase II trial is studying how well giving docetaxel together with cisplatin works in treating patients with stage I, stage II, or stage III non-small cell lung cancer that has been completely removed by surgery.

Checked against the public recordLast updated Jan 17, 2019 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 2
U.S. locations3
SponsorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 2
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Interventions being studied
Drug: cisplatin; Drug: docetaxel; Procedure: adjuvant therapy
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: * Pathologically proven non-small cell lung cancer (NSCLC) * Stage IA-IIIB disease * Underwent prior complete surgical resection (R0) no more than 2 months ago * Eligible for cisplatin-based adjuvant chemotherapy PATIENT CHARACTERISTICS: * Karnofsky performance status ≥ 70% * Absolute neutrophil count ≥ 1,500/mm\^3 * Hemoglobin ≥ 8.0 g/dL * Platelet count ≥ 100,000/mm\^3 * Creatinine clearance \> 55 mL/min * Total bilirubin normal * Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria: * Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit of normal (ULN) * AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN * AP ≤ 5 times ULN AND AST and ALT normal * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 3 months after completion of study treatment * No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80 * No peripheral neuropathy \> grade 1 * No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher) PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior postoperative radiation therapy * No prior chemotherapy for NSCLC * No prior docetaxel or cisplatin * No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim

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

  • Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland
  • Memorial Sloan-Kettering Cancer CenterNew York, New York
  • Vanderbilt-Ingram Cancer CenterNashville, Tennessee

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Jan 17, 2019. Always confirm current availability with the study team.

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