Know Cancer

or
forgot password

A Phase II, Multinational and Multicenter, Randomized, Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-Small Cell Lung Cancer


Phase 2
40 Years
80 Years
Open (Enrolling)
Both
Lung Cancer

Thank you

Trial Information

A Phase II, Multinational and Multicenter, Randomized, Controlled Study of Paclitaxel and Carboplatin With vs Without Nitroglycerin in Patients With Untreated Advanced Non-Small Cell Lung Cancer


OBJECTIVES:

- To evaluate tumor response rate and safety of nitroglycerin as a potentiator of
anticancer combination therapy comprising paclitaxel and carboplatin in patients with
previously untreated stage IIIB or IV non-small cell lung cancer.

OUTLINE: This is a multicenter, randomized, controlled study. Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive nitroglycerin, paclitaxel, and carboplatin.

- Arm II: Patients receive paclitaxel and carboplatin. In both arms, treatment continues
for 6 courses in the absence of disease progression or unacceptable toxicity.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer

- Stage IIIB or IV disease that cannot be treated by radical irradiation

- Tumor lesions must be objectively evaluated according to WHO criteria (maximum
diameter is no shorter than twice the slice width and no shorter than 10 mm) by CT
scan

- No brain metastasis

PATIENT CHARACTERISTICS:

- ECOG performance status 0-1

- Life expectancy ≥ 3 months

- Neutrophil count > 2,000/μL

- Hemoglobin > 10.0 g/dL

- Platelet count > 100,000/μL

- Serum bilirubin < 2.0 mg/dL

- ALT and AST < 100 IU/L

- Serum creatinine < 2.0 mg/dL

- PaO_2 ≥ 70 mm Hg

- No cardiac problems, including any of the following:

- Poorly controlled hypertension

- Unstable angina

- Congestive heart failure

- Myocardial infarction within the past year

- Ventricular arrhythmia that requires treatment except single, well-controlled
isolated ventricular extrasystole

- No chronic active hepatitis or cirrhosis requiring treatment except hepatitis virus
carriers who do not need treatment

- No comorbidity of interstitial pneumonia and pulmonary fibrosis requiring treatment

- No other cancer requiring treatment except a malignant tumor curatively resected with
no recurrence

- No severe psychiatric disorders including schizophrenia or dementia

- Cardiothoracic ratio < 60% by chest x-ray

- No history of severe drug allergy or allergy to polyoxyethylene castor oil (in some
anesthetic drugs or muscle relaxants) or polysorbate 80

- Patients in whom nitroglycerin preparations are contraindicated are not eligible,
including any of the following:

- Severe hypotension (e.g., systolic blood pressure ≤ 80 mm Hg)

- Angle-closure glaucoma

- History of hypersensitivity to nitrate/nitrite ester drugs

- Not pregnant or nursing

PRIOR CONCURRENT THERAPY:

- No prior chemotherapy or radiotherapy

- Pleurodesis is not considered chemotherapy

- At least 1 week since prior and no other concurrent nitric oxide donors (e.g.,
nitroglycerin)

- At least 1 week since prior and no concurrent calcium antagonists

- At least 1 week since prior and no concurrent drugs for erectile dysfunction that
inhibit phosphodiesterase 5 (e.g., sildenafil citrate or vardenafil hydrochloride
hydrate)

- More than 24 hours since prior and no concurrent administration of the following:

- Antifungal azoles, including ketoconazole, miconazole, or itraconazole

- Macrolides, including erythromycin or clarithromycin

- Cyclosporines

- Benzodiazepines, including diazepam, triazolam, or midazolam

- Vitamin A

- Steroid hormones, including ethinylestradiol

- No concurrent participation in another clinical trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Tumor response rate

Safety Issue:

No

Principal Investigator

Hiroyasu Yasuda, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Tohoku University

Authority:

Unspecified

Study ID:

CDR0000584254

NCT ID:

NCT00616031

Start Date:

January 2008

Completion Date:

Related Keywords:

  • Lung Cancer
  • stage IIIB non-small cell lung cancer
  • stage IV non-small cell lung cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location