Phase I Trial of Docetaxel and Low-Dose Fractionated Radiation in the Treatment of Metastatic or Recurrent NSCLC

Phase 1

Terminated

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Drug: Docetaxel; Radiation: Radiation

• Registration Number: NCT00378404
• Lead Sponsor: Susanne Arnold

Brief Summary

The purpose of this study is to assess the maximum tolerated dose of low-dose radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer for second-line therapy.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-09-18
• Study First Submitted QC: 2006-09-19
• Study First Posted: 2006-09-20
• Primary Completion: 2009-06
• Study Completion: 2010-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Patients must be 18 years of age or greater.
• Histologically or cytologically proven non-small cell lung cancer that is either metastatic or recurrent and failed at least one prior platinum-based chemotherapeutic regimen.
• Patients who have recurred after previous surgery and/or radiation may participate in this trial.
• Patients may have had prior neoadjuvant or adjuvant therapy.
• Patients with known brain metastases are eligible for this clinical trial if their disease has been treated and they are clinically stable and documented by a stable or improved pretreatment CT or MRI scan of the brain to evaluate for CNS disease within 28 days prior to registration.
• Measurable OR non-measurable disease documented by CT, MRI, X-ray or nuclear exam (FDG-PET). Measurable or non-measurable disease must be present outside the area of surgical resection. Pleural effusions, ascites and laboratory parameters are not acceptable as the only evidence of disease.
• Progression after at least one prior platinum-based chemotherapy.
• Greater than 3 weeks since surgery and must have recovered from all associated toxicities at time of registration.
• ANC ≥ 1,500/µl and platelet count ≥ 100,000/µl obtained within 28 days prior to registration.
• Adequate hepatic function documented by a serum bilirubin ≤ 1.5 times institutional upper limit of normal and liver enzymes (SGOT or SGPT) ≤ 2.5 x the institutional upper limit of normal obtained within 28 days prior to registration.
• Patients requiring lung radiation must have an FEV1 of > 1000 liters obtained within 28 days prior to registration and must have pulmonary function tests with DLCO.
• Zubrod Performance Status of 0,1 or 2.

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Exclusion Criteria

• No prior single-agent, weekly Docetaxel chemotherapy.
• Peripheral neuropathy ≥ Grade 1.
• Prior malignancy except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission or other cancer from which the patient has been disease-free for 5 years.
• Pregnant or nursing women.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Radiation	-
1	Docetaxel	-

Primary Outcome Measures

Name	Time	Method
To assess the MTD of low-dose fractionated radiation in combination with Docetaxel in recurrent or metastatic non-small cell lung cancer in the second-line setting.	continuously through treatment

Secondary Outcome Measures

Name	Time	Method
Toxicity	continuously throughout treatment
To investigate in an exploratory manner, the association of p53, p21^waf1/cip1, bcl-xL, bcl-2 and bax markers in pre- and post-treatment biopsies with patient response and toxicity.	week 1

Trial Locations

Locations (1)

University of Kentucky; 🇺🇸 Lexington, Kentucky, United States