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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of New Mexico
• Treatments: Topotecan

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