Know Cancer

forgot password

Phase 1/Phase 2
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

Thank you

Trial Information

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.

Inclusion Criteria

Inclusion Criteria

1. Pathologically or cytologically confirmed NSCLC. Histology may include
adenocarcinoma, squamous cell, large cell undifferentiated, but no bronchoalveolar
carcinoma, small cell or carcinoid.

2. Locally advanced NSCLC disease (Stage IIIa or IIIb) or metastatic disease (Stage IV)

3. ECOG performance status 0-2 (See Appendix 1 )

4. Age > 18 years.

5. Absoloute neutrophil count > 1500 / mm3 ,platelet count > 100,000/ mm3

6. 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.

7. Normal serum creatinine (less than 1.5 mg/dl) or creatinine clearance greater than 30
ml/minute (Cockroft and Gault).

8. No history of allergy to the agents being used in this study.

9. 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).

10. If fertile, the patient agrees to use acceptable methods to avoid pregnancy for the
duration of the study.

11. No evidence of CHF, ischemic heart disease (NYHA Class III or IV), or serious
arrhythmias or recent history of myocardial infarction.

12. 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.

13. 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.

14. Patients should have at least a predicted FEV1 of 30%.

15. 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

3.B. Exclusion Criteria Patients meeting any of the following criteria will not be
eligible for the study.

1. Patients with medically uncontrollable hypercoaguability syndromes are not eligible.
Patients who are on therapeutic anticoagulation are not excluded.

2. Patients with weight loss > 10% in previous 3 months.

3. Patients with prior Vinca Alkaloid treatment.

4. 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.

5. Subjects who have had an organ allograft.

6. Patients with known adverse effects to Vinca Alkaloids.

7. Subjects with several renal impairment (creatinine clearance below 30ml/min [Cockroft
and Gault]).

8. Pregnant women and nursing mothers.

9. Sexually active males unwilling to practice contraception during the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:


Principal Investigator

Paul Schwarzenberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Food and Drug Administration

Study ID:

Hypo 3



Start Date:

March 2003

Completion Date:

September 2005

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Hypofractionated chest radiation
  • Oral Navelbine
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung



LSUHSC Shreveport, Louisiana  71130