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

Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322751
• Other study ID #: INST 0529C
• Status: Completed
• Phase: Phase 1
• First received: May 5, 2006
• Last updated: January 6, 2010
• Start date: April 2006
• Est. completion date: November 2009

Study information

• Verified date: November 2009
• Source: University of New Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	University of New Mexico	Albuquerque	New Mexico

Sponsors (1)

Lead Sponsor	Collaborator
University of New Mexico

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint is the establishment of the maximum tolerated dose (MTD) of topotecan given weekly with RT		Treatment with topotecan will last until RT is completed. Treatment will stop if there is disease progression or unacceptable toxicity	Yes