Combination of Weekly Chest Radiotherapy and Oral Navelbine for the Palliation of Advanced Non Small Cell Lung Cancer: A Phase I Study

Phase 1

Completed

• Conditions: Carcinoma, Non-Small-Cell Lung

• Registration Number: NCT00256815
• Lead Sponsor: Clinical Oncology Research Associates

Brief Summary

The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most subjects cannot be cured from the disease, however, treatment can help subjects to live longer and better by keeping the cancer under control. All treatment offered to is primarily pursuing that goal. Subjects at this stage of their disease traditionally receive radiation therapy or chemotherapy, both treatments in succession or both concurrently. Recently, the administration of both methods of treatment concurrently has been employed and indicate somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids used in combination with radiation therapy appear promising as determined in small studies. The drug Navelbine is part of this class of drugs. This drug is approved as an infusion through the veins. The pill form is under development and will be used in this form in this treatment program.

For this protocol, radiation will be administered using a schedule which is more convenient for patients, by once weekly chest irradiation for a total of 12 weeks. Use of this schedule was determined to be as good as the more commonly used daily radiotherapy. The once weekly schedule is less cumbersome as it involves less visits. The rationale and reason why you are being asked to participate in this program is to study whether the drug Navelbine can be given together with the once weekly radiation schedule. Radiation will be administered in two fractions, 6 hours apart on one day. For this program, the drug Navelbine would be made available as a pill, and would not have to be infused through the vein. The proposed protocol will use increasing doses of the drug Navelbine in pill form to find the highest dose of Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject will receive one dose of Navelbine, which is higher than the dose of the previous subject. This escalation will continue until the highest tolerated dose has been determined.

The administration via pill would be easier and avoid previously experienced side effects that were experienced by infusion into the veins of subjects, such as burning and sores at the infusion site.

Detailed Description

35 patients with advanced NSCLC will be enrolled (stages III and IV) and treated once per week in two fractions for a total of 12 cycles using a previous prescription developed by Salazar et al to a total of 6000 rad.

Treatment will be given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas will be radiated as well. The drug Navelbine will be given in a dose escalation on the same day the radiation is administered. The starting dose for Navelbine will be 20 mg/m2 and the escalation will be in 10 mg increments.

Study Timeline

• Study Start: 2003-03
• Status Verified: 2005-09
• Study Completion: 2005-09
• Study First Submitted: 2005-11-21
• Study First Submitted QC: 2005-11-21
• Study First Posted: 2005-11-22
• Last Update Submitted: 2014-02-10
• Last Update Posted: 2014-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety
Toxicity

Secondary Outcome Measures

Name	Time	Method
Efficacy
Survival

Trial Locations

Locations (1)

LSUHSC; 🇺🇸 New Orleans, Louisiana, United States