AzTrials
AzTrials

Carcinoma, Non-Small-Cell LungPhase 1/2NCT00256815

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

A Phase 1/2 study testing chemotherapy and Radiation in people with Carcinoma, Non-Small-Cell Lung, run by Clinical Oncology Research Associates at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… 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
Type of treatment
Surgery or procedure
How many people
35 participants
Where
1 siteUnited States
Study dates
Mar 2003to Sep 2005
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

  • Pathologically or cytologically confirmed NSCLC. Histology may include adenocarcinoma, squamous cell, large cell undifferentiated, but no bronchoalveolar carcinoma, small cell or carcinoid.
  • Locally advanced NSCLC disease (Stage IIIa or IIIb) or metastatic disease (Stage IV)
  • ECOG performance status 0-2 (See Appendix 1 )
  • Age > 18 years.
  • Absoloute neutrophil count > 1500 / mm3 ,platelet count > 100,000/ mm3
  • Serum bilirubin < upper limit of normal (ULN); ALT and AST < 2.5 X ULN if alkaline phosphatase is < ULN. Alkaline phosphatase may be up to 4 X ULN if transaminases are < ULN.
Show all 25Show fewer
  • Normal serum creatinine (less than 1.5 mg/dl) or creatinine clearance greater than 30 ml/minute (Cockroft and Gault).
  • No history of allergy to the agents being used in this study.
  • If female of childbearing potential, pregnancy test is negative and must be practicing approved methods of birth control. (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of nonchildbearing potential).
  • If fertile, the patient agrees to use acceptable methods to avoid pregnancy for the duration of the study.
  • No evidence of CHF, ischemic heart disease (NYHA Class III or IV), or serious arrhythmias or recent history of myocardial infarction.
  • No evidence of active infection or serious concurrent medical illness which would jeopardize the ability of the patient to receive with reasonable safety the chemotherapy and radiation program outlined in this protocol.
  • 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.
  • Patients should have at least a predicted FEV1 of 30%.
  • Signed informed consent has been obtained (see the informed consent form Appendix 2). 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.
  • 3.B. Exclusion Criteria Patients meeting any of the following criteria will not be eligible for the study.
  • Patients with medically uncontrollable hypercoaguability syndromes are not eligible. Patients who are on therapeutic anticoagulation are not excluded.
  • Patients with weight loss > 10% in previous 3 months.
  • Patients with prior Vinca Alkaloid treatment.
  • Subjects where studies or clinical examination demonstrates lack of physical integrity of the upper gastrointestinal tract (e.g. previous significant surgical resection), inability to swallow capsules intact, dysphagia, or those who have malabsorption syndrome.
  • Subjects who have had an organ allograft.
  • Patients with known adverse effects to Vinca Alkaloids.
  • Subjects with several renal impairment (creatinine clearance below 30ml/min [Cockroft and Gault]).
  • Pregnant women and nursing mothers.
  • Sexually active males unwilling to practice contraception during the study.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • LSUHSC

    New Orleans, Louisiana, 70112

Other trials in United States

About this study

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.

Read the 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.

Being tested
chemotherapy, Radiation
Keywords
Hypofractionated chest radiation, Oral Navelbine
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

  • RadiationProcedure or surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety

  2. Toxicity

Secondary outcomes (2)

  1. Efficacy

  2. Survival

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Nov 2005 (estimated)
  2. Study startMar 2003
  3. Study completionSep 2005

Resources

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
35 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00256815
Sponsor's protocol ID
Hypo 3
Status last verified
Sep 2005
First submitted
21 Nov 2005
Last updated
11 Feb 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 15289734

  • Iaffaioli RV, Caponigro F, Tortoriello A, Facchini G, Ravo V, Maccauro M, Dimitri P, Crovella F, Muto P. Accelerated split-course (type B) thoracic radiation therapy plus vinorelbine/carboplatin combination chemotherapy in stage III inoperable non-small cell lung cancer. Eur J Cancer. 1996 Oct;32A(11):1901-4. doi: 10.1016/0959-8049(96)00203-1.

    PubMed 8943672

  • 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.

    PubMed 2839442

  • 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.

    PubMed 3519551

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing chemotherapy and Radiation 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 25 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: finished, as of the sponsor's last update on 11 Feb 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety. The study lists 2 primary outcomes in all. 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 NCT00256815, which also lists 4 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 11 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in