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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)


Phase 1
18 Years
N/A
Not Enrolling
Both
Lung Cancer

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Trial Information

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)


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


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT

Outcome Time Frame:

Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity

Safety Issue:

Yes

Principal Investigator

Dennie Jones, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of New Mexico

Authority:

United States: Institutional Review Board

Study ID:

INST 0529C

NCT ID:

NCT00322751

Start Date:

April 2006

Completion Date:

November 2009

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

University of New MexicoAlbuquerque, New Mexico  87131