Once Weekly Radiation for Lung Cancer With Chemotherapy

NCT00256789 | Completed

• 1 other identifier: Hypo 1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This program is designed for the treatment of patients with advanced non-small cell lung cancer. The study is designed for patients whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. Patients at this stage of their disease traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both methods of treatment has been employed and preliminary studies indicate somewhat better results. Specifically, a new class of chemotherapy agents called taxanes used in combination with radiation therapy appear promising as determined in small studies. However, the best treatment for this type of cancer has not been established yet. One goal of this study is to investigate if the combination of the new drug Taxotere (a drug belonging to the taxane class) given on the day of the radiation is well tolerated and will result in enhanced shrinkage of the cancer compared to traditional radiation therapy. In this study the radiation will be given on one day, rather than divided over five days per week (Monday through Friday) as in previous studies. Previous research has shown that both equal in how effective they are in treating lung cancer. The study will use the drug Taxotere in conjunction with radiation therapy. Taxotere is an approved medicine by the United States Food and Drug Administration for the treatment of lung cancer. The purpose of this study is to evaluate if the chemotherapy drug Taxotere administered once weekly together with concurrent radiation on the same day is effective in shrinking non-small cell lung cancer. This trial will also investigate how well this treatment is tolerated and what effects this treatment will have on the everyday life and activities of participants.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

NSCLC, Non-Small Cell Lung Cancer,Weekly Radiation, Taxotere

Outcome Measures

Primary Outcomes (1)

• Feasibility

Secondary Outcomes (1)

• Toxicity, Safety, Efficacy

Interventions

Radiation PROCEDURE

Chemotherapy DRUG

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must have histologic evidence of NSCLC.
• Should the patient have a history of another malignancy or a second malignancy be present or discovered, subjects will only be eligible if the NSCLC is determined by the PI to be the more life-threatening disease and the other malignancy would not have otherwise a significant impact on the subjects life-expectancy (e.g. basal cell carcinoma of skin, remote history of early stage breast cancer surgically cured).
• All patients must have surgically incurable disease, i.e. locally advanced disease (stage III A or III B) or metastatic stage IV.
• Performance status of 0 to 2 (ECOG Criteria).
• Patients should have an absolute granulocyte count \> 1500/mm3 and a platelet count \> 100,000/mm3.
• Patients should have adequate hepatic function as indicated by a serum bilirubin \< upper limit of normal (ULN); ALT and AST \<2.5 ULN if alkaline phosphatase is \< ULN. Alkaline phosphatase may be up to 4 x ULN if transaminases are \< ULN. However, patients who have both transaminase elevation \> 1.5 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study.
• Patients should have at least a predicted FEV1 of 30%.
• Patients with active ischemic heart disease (NYHA Class III or IV), congestive heart failure, symptomatic arrythmias, or a recent history of a myocardial infarction are excluded.
• Patients with pre-existing neuropathy (\> grade 1) are not eligible for this study.
• No other serious concurrent medical illness or active infection which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and surgery program outlined in this protocol is allowed.
• Signed informed consent: each patient must be aware of the neoplastic nature of his/her disease and willingly consent to participate in the study after being informed of the procedure to be followed, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts.
• Pregnant women and nursing mothers are ineligible. Women of child-bearing potential must have a negative pregnancy test. Women of childbearing potential must be willing to consent to using effective contraception while on treatment and for three months thereafter.
• Patients with a history of severe hypersensitivity reaction to TaxotereÒ or other drugs formulated with polysorbate 80 must be excluded.
• Patients must be at least 18 years old.

You may not qualify if:

• Not falling into the eligibility criteria outlined above

Sponsors & Collaborators

• Clinical Oncology Research Associates: lead
• Aventis Pharmaceuticals: collaborator

Study Sites (1)

Cancer Center and Mobile Infirmary Hospital

Mobile, Alabama, 36607, United States

Location

Related Publications (3)

• Slawson RG, Salazar OM, Poussin-Rosillo H, Amin PP, Strohl R, Sewchand W. Once-a-week vs conventional daily radiation treatment for lung cancer: final report. Int J Radiat Oncol Biol Phys. 1988 Jul;15(1):61-8. doi: 10.1016/0360-3016(88)90347-1.

  PMID: 2839442 BACKGROUND

• Salazar OM, Slawson RG, Poussin-Rosillo H, Amin PP, Sewchand W, Strohl RA. A prospective randomized trial comparing once-a-week vs daily radiation therapy for locally-advanced, non-metastatic, lung cancer: a preliminary report. Int J Radiat Oncol Biol Phys. 1986 May;12(5):779-87. doi: 10.1016/0360-3016(86)90036-2.

  PMID: 3519551 BACKGROUND

• Salazar OM, Van Houtte P, Rubin P. Once-a-week radiation therapy for locally advanced lung cancer. Final report. Cancer. 1984 Aug 15;54(4):719-25. doi: 10.1002/1097-0142(1984)54:43.0.co;2-s.

  PMID: 6744205 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Radiation; Drug Therapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena; Therapeutics

Study Officials

• Paul Schwarzenberger, MD

  Mobile Infirmary Hospital, Mobile, AL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 18, 2005
• First Posted: November 22, 2005
• Study Start: September 1, 2002
• Primary Completion: December 1, 2003
• Study Completion: December 1, 2004
• Last Updated: February 11, 2014

Record last verified: 2005-11

Locations

US (1)