Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

Study summary

RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.

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Key things to know

Main goalTreatment

This describes the study’s primary purpose.

What is being studiedtopotecan hydrochloride and vinorelbine tartrate

The study team can explain what participation involves.

Who it may be forRecurrent or relapsed

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated May 17, 2018 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Phase 1

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Medical University of South Carolina

Study sponsor

Study overview

What this study is about

Purpose: Treatment
Study type: Interventional
Phase: Phase 1
Sponsor: Medical University of South Carolina
Interventions being studied: Drug: topotecan hydrochloride; Drug: vinorelbine tartrate

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How this study is categorized

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

Disease setting

Recurrent or relapsed→

Treatment approach

Chemotherapy→

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:
Histologically or cytologically confirmed lung cancer
All histologic types eligible
Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy PATIENT CHARACTERISTICS:
ECOG performance status (PS) ≤ 2
Karnofsky PS ≥ 60%
Absolute neutrophil count ≥ 1,500/mm\^3
Platelet count ≥ 100,000/mm\^3
Total bilirubin ≤ 1.5 mg/dL
Creatinine ≤ 1.5 mg/dL
Not pregnant or nursing
Fertile patients must use effective contraception
No other active invasive malignancy
No uncontrolled illness including, but not limited to:
Ongoing or active infection
Symptomatic congestive heart failure
Unstable angina pectoris
Cardiac arrhythmia
No psychiatric illness/social situation that would limit compliance with study requirements
No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate PRIOR CONCURRENT THERAPY:
See Disease Characteristics
At least 2 weeks since prior radiotherapy
No prior therapy with topotecan or vinorelbine ditartrate
No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
Recovered from agents administered \> 4 weeks earlier
No other concurrent investigational agents
No concurrent palliative radiotherapy
No other concurrent anticancer therapies or agents
No concurrent hormones or other chemotherapy except for the following:
Steroids for adrenal failure
Hormones for nondisease-related conditions (e.g., insulin for diabetes)
Intermittent dexamethasone as an antiemetic

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

Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina

Source and freshness
Processed from ClinicalTrials.gov. Last public update: May 17, 2018. Always confirm current availability with the study team.

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