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

Completed · Phase 1

Conditions studied: Lung Cancer

In brief

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.

Key facts

Study ID

NCT00322751

Run by

University of New Mexico

People needed

10

Starts

2006-04-01

Expected to finish

2009-11-01

Last updated by the study team

2010-01-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of New Mexico — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.