Lung CancerPhase 3NCT00017407
Carboplatin and Paclitaxel With or Without ISIS 3521 in Treating Patients With Non-Small Cell Lung Cancer
A Phase 3 study testing ISIS 3521, carboplatin and paclitaxel in people with Lung Cancer, run by Ionis Pharmaceuticals, Inc. at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- ISIS 3521, carboplatin and paclitaxel
- How many people
- Not given
- Where
- 2 sitesUnited States
- Study dates
- 13 Oct 2000to 9 Sep 2002
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
ISIS Pharmaceuticals, Inc.
Carlsbad, California, 92008
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Lung Cancer
- Being tested
- ISIS 3521, carboplatin, paclitaxel
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ISIS 3521Biological
carboplatinDrug
paclitaxelDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2004 (estimated)
- Study start13 Oct 2000
- Primary completion9 Sep 2002
- Study completion9 Sep 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Ionis Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Ionis Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Jon Holmlund, MD, Study chair, Ionis Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00017407
- Sponsor's protocol ID
- CDR0000068686
- Other IDs
- ISIS-3521-CS17, CWRU-040123, ISIS-1501
- Status last verified
- Dec 2006
- First submitted
- 6 Jun 2001
- Last updated
- 5 Dec 2022
- Results posted
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00017407
- Acronym / sponsor ID
- CDR0000068686
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Ionis Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2000 (actual)
- Primary completion
- 9 Sep 2002 (actual)
- Study completion
- 9 Sep 2002 (actual)
- First posted
- 4 Feb 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ISIS 3521 | Biological | – |
| carboplatin | Drug | – |
| paclitaxel | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Results publicationLinch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jon Holmlund, MD study chair
Ionis Pharmaceuticals, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ISIS 3521, carboplatin and paclitaxel in people with Lung Cancer, run by Ionis Pharmaceuticals, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00017407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2022.