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Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer

This study has been completed.
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00322751
First received: May 5, 2006
Last updated: January 6, 2010
Last verified: November 2009
History of Changes
  Purpose

Given the activity of single-agent Topotecan in NSCLC, there is both scientific rationale and a medical interest in studying this agent in combination with radiation. In addition, Topotecan administered on a weekly basis offers advantages over the daily x 5 regimen, i.e., the convenience of administration and fewer visits to the clinic.


Condition Intervention Phase
Lung Cancer
 Drug: Topotecan
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I Study of Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer (NSCLC) (Stage I to IIIA)

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer
U.S. FDA Resources

Further study details as provided by University of New Mexico:

Primary Outcome Measures:
  • The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT [ Time Frame: Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 10
Study Start Date: April 2006
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Topotecan
    The starting dose for the first cohort will be 2 mg/m2/week. Increment between cohorts will be by 1 mg/m2/week if no toxicity related to topotecan occurs. All members of a dose cohort must have safely completed all radiotherapy and topotecan dosing prior to beginning enrollment in the next higher dose cohort. Increments will be reduced to 0.5 mg/m2 if mild to moderate toxicity occurs (grades 1 or 2). The escalation will continue until the maximum dose of 4 mg/m2/week is reached. Therefore the minimum number of dose levels (cohorts) is 3 to reach the goal of 4 mg/m2/week, and the maximum is 5.
Detailed Description:

This is a study of chemoradiation for patient with inoperable non small cell lung cancer with poor pulmonary function. These patients have usually very limited treatment options because of the compromised lung function. Chemoradiation is usually superior to radiation alone, but has not been extensively tested in this patient population. Topotecan is a drug approved for lung cancer that has synergistic activity with radiation. The study will determine what is the safest dose of topotecan to use with radiation in this patient population

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with histologically proven non-small cell lung cancer Stage I to IIIA.
  • Inoperable lung cancer because of poor respiratory lung function, or other medical reasons, as determined by the thoracic surgeon.
  • PS < 2
  • Age > 18 years
  • Life expectancy of > 12 weeks
  • Normal hematologic, liver, and renal function
  • No metastatic disease as determined by CT-PET scanning and bone scan.
  • No brain metastasis by MRI
  • No contraindication to radiotherapy

Exclusion Criteria:

  • Patients with uncontrolled CNS metastases.
  • Active systemic infection.
  • Serious, uncontrolled intercurrent medical or psychiatric illness.
  • Secondary active primary malignancy.
  • Inability to comply with requirements of the study.
  • Any metastases outside of the mediastinum
  • Histologically positive pleural or pericardial effusion
  • Any chemotherapy within five years prior to enrollment on this protocol
  • Prior radiotherapy administered to the chest
  • Women who are pregnant or lactating
  • FEV1 < 1 liter/minute
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00322751

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Dennie Jones, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Dennie Jones, MD; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00322751     History of Changes
Other Study ID Numbers: INST 0529C
Study First Received: May 5, 2006
Last Updated: January 6, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
 Respiratory Tract Diseases
Topotecan
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013