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

Study summary

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.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedcisplatin and docetaxel

Plus 1 other study approaches.

Who it may be forNon-small cell lung cancer (NSCLC) · Early-stage or resectable · Locally advanced

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 2

Interventional

Where is it offered?3 U.S. locations

Locations may change over time.

Who runs it?Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Study sponsor

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

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How this study is categorized

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

Cancer type

Non-small cell lung cancer (NSCLC)→

Disease setting

Early-stage or resectable→Locally advanced→

Treatment approach

Chemotherapy→Surgery→

Study topics

After surgery (adjuvant)→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

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.

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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