Carcinoma, Non-Small-Cell LungPhase 1/2NCT00256841
Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy
A Phase 1/2 study testing Chemotherapy and Radiation Therapy in people with Carcinoma, Non-Small-Cell Lung, run by Clinical Oncology Research Associates at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- What is being tested?
- Chemotherapy and Radiation Therapy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Oct 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
- Signed informed consent: each patient must be aware of the neoplastic nature of his/her disease and willingly consent 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. Eligible patients of reproductive age should use contraception. Woman of childbearing potential with either a positive or no pregnancy test at baseline. Woman of childbearing potential not using a reliable and appropriate contraceptive method. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Sexually active males unwilling to practice contraception during the study will not be eligible.
- Patients must be at least 18 years old.
- Known HIV positive patients will not be eligible.
- Patients with prior treatment of Taxotere, Xeloda or 5FU will not be eligible.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mobile Infirmary Medical Center
Mobile, Alabama, 36607
About this study
Official title: Dose Escalation of Xeloda or 5FU Continuous Infusion in Combination With Taxotere and Concurrent Once Weekly, Hypofractionated Chest Radiotherapy for Advanced Non Small Cell Lung Cancer: A Phase I/II Study
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.
Read more
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.
Read the detailed description
The original once weekly hypofractionated chest irradiation protocol descrived by Salazar et al. will be followed with a slight modification. The dose will be split in two fractions, which will be given 6 hours apart. We found that this fractionation in two doses reduces radiation-related side effects. 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. A total of 12 treatments will be administered in weekly. Total treatment will be 6000 cGy. Radiation treatment will be administered within 2 hours of Taxotere infusion.
All patients will receive a fixed dose of Taxotere of 25 mg/m2 once per week on the day of radiotherapy preceeding the radiation. All patients will be premedicated using standard antiemetics and Decadron (8 mg po 12 hours prior Taxotere, 1 mg Kytril po, 20 mg Decadron iv , 50 mg Benadryl iv and 20 mg Pepcid iv , all 30 min prior Taxotere).
A dose escalation of 5-FU or Xeloda will be employed. 5-FU will be given as continuous infusion, Xeloda orally Monday through Friday throughout the 12 weeks of radiation. Upon reaching the maximum tolerated dose, the remainder of patients will be treated at the 5-FU/Xeloda dose level below the MTD.
Patients for who are unable to tolerate oral Xeloda because of the size of the tablets or difficulties with their upper gastroiontestinal tract or for whom Xeloda cannot be obtained, the intravenous equivalent of 5-Fluorouracil (5-FU) will be administered as a continuous intravenous infusion. Patients who started out on Xeloda and during the treatment experience difficulties in continuing taking Xeloda maybe switched to a biological equivalent dose of 5-FU during the treatment. The 5-FU dose range administered in lieu of Xeloda will be administered and adjustments will be made in 50 mg/m2/day steps as previously pubished by Lokich et al.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- Chemotherapy, Radiation Therapy
- Keywords
- Hypofractionated Chest Radiation, Taxotere, 5-FU
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Radiation TherapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Saftey
Secondary outcomes (2)
Efficacy
Survival
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startSep 2005
- Study completionOct 2007
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Oncology Research Associates
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paul Schwarzenberger, MD, Clinical Oncology Research Associates
- Investigators
- Paul Schwarzenberger, MD, Principal investigator, Lyv Life Inc. (dba: Cora)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00256841
- Sponsor's protocol ID
- Hypo 2
- Status last verified
- Jan 2014
- First submitted
- 21 Nov 2005
- Last updated
- 29 Jan 2014
- Results posted
- No
Publications
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.
PubMed 15289734Salazar 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.
PubMed 3519551Salazar 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.
PubMed 6744205Slawson 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.
PubMed 2839442O'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.
PubMed 12065558
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Escalation of Xeloda or 5FU Continuous Infusion in Combination With Taxotere and Concurrent Once Weekly, Hypofractionated Chest Radiotherapy for Advanced Non Small Cell Lung Cancer: A Phase I/II Study
- ClinicalTrials.gov ID
- NCT00256841
- Acronym / sponsor ID
- Hypo 2
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Keywords
- Hypofractionated Chest Radiation, Taxotere, 5-FU
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clinical Oncology Research AssociatesUniversity, hospital or other
- Study start
- Sep 2005
- Study completion
- Oct 2007 (actual)
- First posted
- 22 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The original once weekly hypofractionated chest irradiation protocol descrived by Salazar et al. will be followed with a slight modification. The dose will be split in two fractions, which will be given 6 hours apart. We found that this fractionation in two doses reduces radiation-related side effects. 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. A total of 12 treatments will be administered in weekly. Total treatment will be 6000 cGy. Radiation treatment will be administered within 2 hours of Taxotere infusion.
All patients will receive a fixed dose of Taxotere of 25 mg/m2 once per week on the day of radiotherapy preceeding the radiation. All patients will be premedicated using standard antiemetics and Decadron (8 mg po 12 hours prior Taxotere, 1 mg Kytril po, 20 mg Decadron iv , 50 mg Benadryl iv and 20 mg Pepcid iv , all 30 min prior Taxotere).
A dose escalation of 5-FU or Xeloda will be employed. 5-FU will be given as continuous infusion, Xeloda orally Monday through Friday throughout the 12 weeks of radiation. Upon reaching the maximum tolerated dose, the remainder of patients will be treated at the 5-FU/Xeloda dose level below the MTD.
Patients for who are unable to tolerate oral Xeloda because of the size of the tablets or difficulties with their upper gastroiontestinal tract or for whom Xeloda cannot be obtained, the intravenous equivalent of 5-Fluorouracil (5-FU) will be administered as a continuous intravenous infusion. Patients who started out on Xeloda and during the treatment experience difficulties in continuing taking Xeloda maybe switched to a biological equivalent dose of 5-FU during the treatment. The 5-FU dose range administered in lieu of Xeloda will be administered and adjustments will be made in 50 mg/m2/day steps as previously pubished by Lokich et al.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (21 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chemotherapy | Drug | – |
| Radiation Therapy | Procedure or surgery | – |
Primary outcome
Saftey
2 secondary outcomes
Efficacy
Survival
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
- Background: PubMed 15289734Schwarzenberger 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.
- Background: PubMed 3519551Salazar 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.
- Background: PubMed 6744205Salazar 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.
- Background: PubMed 2839442Slawson 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.
- Background: PubMed 12065558O'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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paul Schwarzenberger, MD principal investigator
Lyv Life Inc. (dba: Cora)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Chemotherapy and Radiation Therapy in people with Carcinoma, Non-Small-Cell Lung, run by Clinical Oncology Research Associates at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saftey. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00256841, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2014.