NCT00017407

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Oct 2000

Shorter than P25 for phase_3 lung-cancer

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2000

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2001

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2002

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 9, 2002

Completed
1.4 years until next milestone

First Posted

Study publicly available on registry

February 4, 2004

Completed
Last Updated

December 5, 2022

Status Verified

December 1, 2006

Enrollment Period

1.9 years

First QC Date

June 6, 2001

Last Update Submit

December 1, 2022

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancerstage IIIB non-small cell lung cancerstage IV non-small cell lung cancer

Interventions

ISIS 3521BIOLOGICAL
carboplatinDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

ISIS Pharmaceuticals, Inc.

Carlsbad, California, 92008, United States

Location

Ireland Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

Related Publications (1)

  • Linch TJ, Raju R, Lind M, et al.: Randomized phase III trial of chemotherapy and antisense oligonucleotide LY00003 (ISIS 3521) in patients with advanced NSCLC. [Abstract] Lung Cancer 41 (Suppl 2): A-O-108, S35, 2003.

    RESULT

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

ISIS 3521CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Jon Holmlund, MD

    Ionis Pharmaceuticals, Inc.

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Purpose
TREATMENT
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

June 6, 2001

First Posted

February 4, 2004

Study Start

October 13, 2000

Primary Completion

September 9, 2002

Study Completion

September 9, 2002

Last Updated

December 5, 2022

Record last verified: 2006-12

Locations

US(2)