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A Prospective, Randomized, Open-Label, Phase III Trial of Chemotherapy With Carboplatin And Paclitaxel, Versus Carboplatin And Paclitaxel In Combination With ISIS-3521, An Antisense Inhibitor Of Protein Kinase C Alpha In Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer


Phase 3
18 Years
N/A
Not Enrolling
Both
Lung Cancer

Thank you

Trial Information

A Prospective, Randomized, Open-Label, Phase III Trial of Chemotherapy With Carboplatin And Paclitaxel, Versus Carboplatin And Paclitaxel In Combination With ISIS-3521, An Antisense Inhibitor Of Protein Kinase C Alpha In Patients With Advanced, Previously Untreated Non-Small Cell Lung Cancer


OBJECTIVES: I. Compare the overall survival of patients with stage IIIB or IV non-small cell
lung cancer treated with carboplatin and paclitaxel with vs without ISIS 3521. II. Compare
the time to tumor progression and time to treatment failure in patients treated with these
regimens. III. Compare the overall (complete plus partial) response rate in patients with
measurable disease treated with these regimens. IV. Compare the percentage of patients with
non-measurable, evaluable disease who have a complete response after treatment with these
regimens. V. Compare the duration of response in patients with a complete or partial
response after treatment with these regimens. VI. Compare the safety of these regimens in
these patients.

OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to tumor stage (IIIB vs IV) and prior brain metastases (yes vs no). Patients are
randomized to one of two treatment arms. Arm I: Patients receive paclitaxel IV over 3 hours
and carboplatin IV over 1 hour on day 0. Arm II: Patients receive ISIS 3521 IV continuously
on days 0-14 and paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 3.
Treatment repeats every 21 days in the absence of disease progression or unacceptable
toxicity. Patients with stable or responsive disease receive 6 courses of treatment.
Patients with responsive disease may receive additional courses of treatment. Patients are
followed at 1, 2, 4, and 6 months and then every 3 months thereafter.

PROJECTED ACCRUAL: Approximately 600 patients (300 per treatment arm) will be accrued for
this study within 15 months.

Inclusion Criteria


DISEASE CHARACTERISTICS: Histologically or cytologically confirmed non-small cell lung
cancer (NSCLC) Stage IV OR Stage IIIB with malignant pleural or pericardial effusion At
least 1 unidimensionally measurable lesion At least 10 mm by spiral CT scan OR At least 20
mm by standard techniques OR Evaluable, non-measurable disease (e.g., ascites, bone
metastases, or malignant pleural or pericardial effusion) No CNS metastases other than
lesions locally treated with surgery or radiosurgery, provided there was no evidence of
CNS progression for at least 4 weeks after completion of treatment No prior or concurrent
brain or other CNS metastases not amenable to local therapy (e.g., multiple brain lesions
or meningeal involvement) Not a candidate for surgical treatment of NSCLC

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-1 Life expectancy:
Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count
at least 100,000/mm3 Hemoglobin at least 10.0 g/dL No underlying disease associated with
active bleeding Hepatic: Bilirubin no greater than 1.5 mg/dL AST less than 3 times upper
limit of normal (ULN) (5 times ULN in the presence of liver metastases) Renal: Creatinine
no greater than 1.5 mg/dL Other: No active infection requiring therapy No other malignancy
within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer
Not pregnant or nursing Negative pregnancy test Fertile patients must use effective
contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior approved or experimental biologic
therapy for NSCLC Chemotherapy: No prior approved or experimental chemotherapy for NSCLC
Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 2
weeks since prior radiotherapy and recovered No prior radiotherapy to indicator lesion(s)
unless an increase in lesion size occurred after completion of radiotherapy Concurrent
localized palliative therapy allowed if pre-approved by sponsor Surgery: See Disease
Characteristics Other: At least 30 days since prior participation in other investigational
study No other concurrent therapy for NSCLC No other concurrent experimental drugs or
anticancer therapy during active treatment of study

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Jon Holmlund, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Isis Pharmaceuticals

Authority:

United States: Federal Government

Study ID:

CDR0000068686

NCT ID:

NCT00017407

Start Date:

October 2000

Completion Date:

Related Keywords:

  • Lung Cancer
  • recurrent non-small cell 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

Ireland Cancer CenterCleveland, Ohio  44106-5065
ISIS Pharmaceuticals, Inc.Carlsbad, California  92008