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Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00287963
Recruitment Status : Completed
First Posted : February 7, 2006
Last Update Posted : May 17, 2018
Information provided by (Responsible Party):
Medical University of South Carolina

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: topotecan hydrochloride Drug: vinorelbine tartrate Phase 1

Detailed Description:



  • Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.


  • Assess the response and stable disease rates and the time to disease progression among treated patients.

OUTLINE: This is a dose-escalation study of topotecan.

Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
Study Start Date : February 2004
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Arm Intervention/treatment
Experimental: Vinorelbine + topotecan Drug: topotecan hydrochloride
Drug: vinorelbine tartrate

Primary Outcome Measures :
  1. Maximum tolerated dose [ Time Frame: Cycle 1 (up to day 21) ]

Secondary Outcome Measures :
  1. Response rate [ Time Frame: while on study, at the end of each 3 week cycle ]
  2. stable disease rate [ Time Frame: while on study, at the end of each 3 week cycle ]
  3. time to progression [ Time Frame: from start of treatment to day of documented progression or death, whichever comes first, up to 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically or cytologically confirmed lung cancer

    • All histologic types eligible
    • Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy


  • 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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00287963

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United States, South Carolina
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
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Study Chair: Andrew S. Kraft, MD Medical University of South Carolina
Study Chair: Gustavo Leone Medical University of South Carolina, Hollings Cancer Center
Publications of Results:
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Responsible Party: Medical University of South Carolina Identifier: NCT00287963    
Other Study ID Numbers: CDR0000454919
First Posted: February 7, 2006    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Keywords provided by Medical University of South Carolina:
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
combined type small cell lung cancer
intermediate type small cell lung cancer
large cell lung cancer
lymphocyte-like type small cell lung cancer
recurrent non-small cell lung cancer
recurrent small cell lung cancer
squamous cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators