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Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer
This study is ongoing, but not recruiting participants.
Sponsored by: Medical University of South Carolina
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00287963
  Purpose

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 Intervention Phase
Lung Cancer
Drug: topotecan hydrochloride
Drug: vinorelbine ditartrate
Phase I

MedlinePlus related topics: Cancer Lung Cancer
Drug Information available for: Vinorelbine Vinorelbine tartrate Topotecan hydrochloride Topotecan
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Response rate, stable disease rate, and time to progression by RECIST criteria on day 1 of each course [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: February 2004
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00287963

Locations
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
Investigators
Study Chair: Andrew S. Kraft, MD Medical University of South Carolina
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications of Results:
Study ID Numbers: CDR0000454919, MUSC-104864/725, GSK-100780
Study First Received: February 6, 2006
Last Updated: November 8, 2008
ClinicalTrials.gov Identifier: NCT00287963  
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Adenocarcinoma, Bronchiolo-Alveolar
Vinblastine
Recurrence
Carcinoma, Small Cell
Adenocarcinoma of lung
Vinorelbine
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Adenocarcinoma
Topotecan
Carcinoma, Non-Small-Cell Lung

Additional relevant MeSH terms:
Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Mitosis Modulators
Tubulin Modulators
Enzyme Inhibitors
Antimitotic Agents
Antineoplastic Agents, Phytogenic
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009