CompletedPhase 3NCT00017407

Carboplatin and Paclitaxel With or Without ISIS 3521 in Treating Patients With Non-Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. ISIS 3521 may help kill more cancer cells by making tumor cells more sensitive to chemotherapy. It is not yet known if carboplatin and paclitaxel are more effective with or without ISIS 3521. PURPOSE: Randomized phase III trial to compare the effectiveness of carboplatin and paclitaxel with or without ISIS 3521 in treating patients who have stage IIIB or stage IV non-small cell lung cancer.

Checked against the public recordLast updated Dec 5, 2022 · Source: ClinicalTrials.gov

StatusCompleted
PhasePhase 3
U.S. locations2
SponsorIonis Pharmaceuticals, Inc.
01
Study overview

What this study is about

Purpose
Treatment
Study type
Interventional
Phase
Phase 3
Sponsor
Ionis Pharmaceuticals, Inc.
Interventions being studied
Biological: ISIS 3521; Drug: carboplatin; Drug: paclitaxel
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

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

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • ISIS Pharmaceuticals, Inc.Carlsbad, California
  • Ireland Cancer CenterCleveland, Ohio

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Dec 5, 2022. Always confirm current availability with the study team.

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