CompletedPhase 1NCT00287963

Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

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.

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

StatusCompleted
PhasePhase 1
U.S. locations1
SponsorMedical University of South Carolina
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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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Explore related studies

How this study is categorized

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

Treatment approach
03
Public criteria

Who may be able to participate

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.

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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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