Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy

NCT00256841 | Withdrawn Phase 1

• 1 other identifier: Hypo 2
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed for patients with non small cell lung cancer 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 patients cannot be cured from the disease, however, treatment can help to live longer and better by keeping the cancer under control. For that purpose, patients traditionally receive radiation therapy or chemotherapy or both treatments in succession. Recently, the administration of both treatment methods given concurrently showed somewhat better results when compared to successive administration. In some studies the drug Taxotere together with radiation performed well in keeping the cancer better under control. Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called "Xeloda" enhanced its anti cancer activity substantially. One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation. Using X-rays, the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread. In this study the radiation will be given on only one day per week in two sessions, rather than divided over five days per week (Monday through Friday) as it is more commonly used. However, both schedules have been found to be equally effective. The treatment program will use increasing doses of the 5-FU medication, either as infusion or as pill to find the highest dose that is tolerated. Once the highest tolerated dose is determined, subsequent patients who will be enrolled will continue to be treated at that dose level. The dose of the drug Taxotere will remain the same throughout. Hypothesis: Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy.

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Hypofractionated Chest Radiation; Taxotere; 5-FU

Outcome Measures

Primary Outcomes (1)

• Saftey

Secondary Outcomes (2)

• Efficacy

• Survival

Interventions

Chemotherapy DRUG

Radiation Therapy PROCEDURE

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. Patients with bronchoalveolar type of NSCLCA are not eligible.
• Should a second malignancy be present or discovered, subjects will only be eligible if the NSCLCA is determined by the PI to be the more life-threatening disease compared to the other malignancy in regards of life-expectancy.
• All patients must have locally advanced disease (stage III A or III B) or metastatic (stage 4). Other stages are not eligible.
• Performance status of 0 -1 (ECOG Criteria).
• Patients should have an absolute granulocyte count \> 1000/mm3 and a platelet count \> 80,000/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 \> 2 x ULN and alkaline phosphatase \> 2.5 x ULN are not eligible for this study.
• Subjects with with severe renal impairment (creatinine clearance below 30 mL/min \[Cockroft and Gault\]) are ineligible.
• 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 medically uncontrollable hypercoagalbility syndromes are not eligible. Patients who are on therapeutic anticoagulation are not excluded.
• Patients with pre-existing serious adverse effects to 5-FU are not eligible for this study. Specifically, subjects with prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
• Patients with medical contraindications to Taxanes are not eligible.
• 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.
• Subjects where studies or clinical examination demonstrates lack of physical integrity of the upper gastrointestinal tract, inability to swallow tablets or those who have malabsorption syndrome are not eligible.
• Subjects who have had an organ allograft are not eligible.

Sponsors & Collaborators

• Clinical Oncology Research Associates: lead

Study Sites (1)

Mobile Infirmary Medical Center

Mobile, Alabama, 36607, United States

Location

Related Publications (5)

• Schwarzenberger P, Theodossiou C, Barron S, Diethelm L, Boyle M, Harrison L, Wynn RB, Salazar OM, Fariss A. Dose escalation of docetaxel concomitant with hypofractionated, once weekly chest radiotherapy for non-small-cell lung cancer: a phase I study. Am J Clin Oncol. 2004 Aug;27(4):395-9. doi: 10.1097/01.coc.0000131943.02929.ac.

  PMID: 15289734 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

• 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

• O'Shaughnessy J, Miles D, Vukelja S, Moiseyenko V, Ayoub JP, Cervantes G, Fumoleau P, Jones S, Lui WY, Mauriac L, Twelves C, Van Hazel G, Verma S, Leonard R. Superior survival with capecitabine plus docetaxel combination therapy in anthracycline-pretreated patients with advanced breast cancer: phase III trial results. J Clin Oncol. 2002 Jun 15;20(12):2812-23. doi: 10.1200/JCO.2002.09.002.

  PMID: 12065558 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Drug Therapy; Radiotherapy

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)

Therapeutics

Study Officials

• Paul Schwarzenberger, MD

  CORA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Oncologist

Study Record Dates

• First Submitted: November 21, 2005
• First Posted: November 22, 2005
• Study Start: September 1, 2005
• Study Completion: October 1, 2007
• Last Updated: January 29, 2014

Record last verified: 2014-01

Locations

US (1)