Clinical trial NCT00322751: Concurrent Radiotherapy With Weekly Topotecan for Primary Treatment of Inoperable Localized Non-small Cell Lung Cancer
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Lung Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-08
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT
timeFrame: Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Dennie Jones, MD
role: PRINCIPAL_INVESTIGATOR
References: