Lung CancerPhase 2NCT00062010

Interferon Alfa, Isotretinoin, and Paclitaxel in Treating Patients With Recurrent Small Cell Lung Cancer

A Phase 2 study testing interferon alpha, 13-cis-retinoic acid and paclitaxel in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 73 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Cancer
What is being tested?: interferon alpha, 13-cis-retinoic acid and paclitaxel
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 37 participants
Where: 73 sitesUnited States
Study dates: 26 May 2004to Aug 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with clinically confirmed measurable disease
Age 18 and over
ECOG Performance status 0-3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Bilirubin no greater than 1.5 mg/dL

Show all 11Show fewer

AST no greater than 2 times upper limit of normal (ULN)
Creatinine no greater than 1.5 mg/dL
Triglycerides no greater than 1.5 times ULN
Patients must have had prior chemotherapy treatment for SCLC, and toxicities must have resolved to less than or equal to grade 1
Women of childbearing potential and sexually active males are strongly encouraged to use an accepted and effective method of contraception.

Who cannot join

History of another neoplasm other than SCLC except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy at least 5 years before registration
Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to registration
Severe depression requiring medication
Use of the following drugs within 4 weeks prior to registration: carbamazepine, ethanol, tetracycline, doxycycline, minocycline, topical acne products containing Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs
Use of GM-CSF or G-CSF within 4 weeks prior to registration
Prior paclitaxel or interferon therapy
Radiation therapy within 60 days prior to registration
Chemotherapy within 60 days prior to registration

Trial locations and contacts

73 sites in 1 country.

City, postcode or hospital

73 sites in 1 country

United States73 sites

Akron City Hospital
Akron, Ohio, 44309-2090
Rush-Copley Cancer Care Center
Aurora, Illinois, 60507
Bryn Mawr Hospital
Bryn Mawr, Pennsylvania, 19010
West Virginia University - Robert C. Byrd Health Sciences Center - Charleston Division
Charleston, West Virginia, 25304
Adena Regional Medical Center
Chillicothe, Ohio, 45601
Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
MetroHealth Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, 44109
Riverside Methodist Hospital Cancer Care
Columbus, Ohio, 43214-3998
CCOP - Columbus
Columbus, Ohio, 43215
Grant Medical Center Cancer Care
Columbus, Ohio, 43215
Mount Carmel Health - West Hospital
Columbus, Ohio, 43222
Doctors Hospital at Ohio Health
Columbus, Ohio, 43228
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
Grady Memorial Hospital
Delaware, Ohio, 43015
Mercy Capitol Hospital
Des Moines, Iowa, 50307
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates at John Stoddard Cancer Center
Des Moines, Iowa, 50309
Medical Oncology and Hematology Associates at Mercy Cancer Center
Des Moines, Iowa, 50314
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines, Iowa, 50314
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines, Iowa, 50316
Duluth Clinic Cancer Center - Duluth
Duluth, Minnesota, 55805-1983
CCOP - Duluth
Duluth, Minnesota, 55805
Miller - Dwan Medical Center
Duluth, Minnesota, 55805
Elkhart General Hospital
Elkhart, Indiana, 46515
Hunterdon Regional Cancer Center at Hunterdon Medical Center
Flemington, New Jersey, 08822
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, 60521
Hutchinson Area Health Care
Hutchinson, Minnesota, 55350
Joliet Oncology-Hematology Associates, Limited - West
Joliet, Illinois, 60435
Borgess Medical Center
Kalamazoo, Michigan, 49001
West Michigan Cancer Center
Kalamazoo, Michigan, 49007-3731
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
Howard Community Hospital
Kokomo, Indiana, 46904
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, 54601
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, 46350
Fairfield Medical Center
Lancaster, Ohio, 43130
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
CCOP - Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106
St. Rita's Medical Center
Lima, Ohio, 45801
Cancer Resource Center - Lincoln
Lincoln, Nebraska, 68510
Meeker County Memorial Hospital
Litchfield, Minnesota, 55355
HealthEast Cancer Care at St. John's Hospital
Maplewood, Minnesota, 55109
Strecker Cancer Center at Marietta Memorial Hospital
Marietta, Ohio, 45750
Saint Anthony Memorial Health Centers
Michigan City, Indiana, 46360
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital
Minneapolis, Minnesota, 55407
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, 55415
Mary Babb Randolph Cancer Center at West Virginia University Hospitals
Morgantown, West Virginia, 26506
Licking Memorial Cancer Care Program at Licking Memorial Hospital
Newark, Ohio, 43055
CCOP - Missouri Valley Cancer Consortium
Omaha, Nebraska, 68106
McCreery Cancer Center at Ottumwa Regional
Ottumwa, Iowa, 52501
Cancer Center of Paoli Memorial Hospital
Paoli, Pennsylvania, 19301-1792
Swedish-American Regional Cancer Center
Rockford, Illinois, 61104-2315
Lakeland Regional Cancer Care Center - St. Joseph
Saint Joseph, Michigan, 49085
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, 55101
HealthEast Cancer Care at St. Joseph's Hospital
Saint Paul, Minnesota, 55102
St. Francis Cancer Center at St. Francis Medical Center
Shakopee, Minnesota, 55379
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Medical X-Ray Center, PC
Sioux Falls, South Dakota, 57105
Sanford Cancer Center at Sanford USD Medical Center
Sioux Falls, South Dakota, 57117-5039
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, 46601
Memorial Hospital of South Bend
South Bend, Indiana, 46601
Saint Joseph Regional Medical Center
South Bend, Indiana, 46617
Mercy Medical Center
Springfield, Ohio, 45504
Community Hospital of Springfield and Clark County
Springfield, Ohio, 45505
Our Lady of Mercy Medical Center Comprehensive Cancer Center
The Bronx, New York, 10466
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
Mount Carmel St. Ann's Cancer Center
Westerville, Ohio, 43081
HealthEast Cancer Care at Woodwinds Health Campus
Woodbury, Minnesota, 55125
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
Lankenau Cancer Center at Lankenau Hospital
Wynnewood, Pennsylvania, 19096
Genesis - Good Samaritan Hospital
Zanesville, Ohio, 43701

Other trials in United States

About this study

Official title: Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer

RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

Read the detailed description

OBJECTIVES:

Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
Determine the toxic effects of this regimen in these patients.
Determine the duration of survival in patients treated with this regimen.
Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Conditions: Lung Cancer
Being tested: interferon alpha, 13-cis-retinoic acid, paclitaxel
Keywords: recurrent small cell lung cancer
Medical subject headings: Lung Neoplasms, Small Cell Lung Carcinoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

interferon alphaBiological
Also called Interferon Alpha-2b, Intron-A, IFN-alpha 2b, NSC# 377523
Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
13-cis-retinoic acidDrug
Also called Isotretinoin, RO-43,780, Accutane, Cistane
13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.
paclitaxelDrug
Also called Taxol, NSC #125973
paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.

Study groups in NCT00062010
Study group	Role	What they receive
IFN-alpha, 13-CRA, paclitaxel	Experimental	Interferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle Receives: Biological: interferon alpha; Drug: 13-cis-retinoic acid; Drug: paclitaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

Response by RECIST Criteria (v 1.0)
Number of eligible, treated participants in each response category by RECIST criteria
Measured: Assessed every 6 weeks

Secondary outcomes (2)

Survival
Time from registration to death.
Measured: Assessed every 3 months for 1 year then every 6 months
Progression-free Survival
Time from registration to documented disease progression (RECIST criteria) or death.
Measured: Assessed every 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 May 2004Aug 2012

First posted6 Jun 2003 (estimated)
Study start26 May 2004
Primary completionMay 2011
Study completionAug 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lung CancerStudies of the same condition, open and under way.
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 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 37 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00062010
Sponsor's protocol ID: CDR0000304430
Other IDs: E6501
Status last verified: Jun 2023
First submitted: 5 Jun 2003
Last updated: 7 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Interferon Alpha (NSC# 377523) Plus 13-Cis-Retinoic Acid Modulation Of BCL-2 Plus Paclitaxel For Recurrent Small Cell Lung Cancer
ClinicalTrials.gov ID: NCT00062010
Acronym / sponsor ID: CDR0000304430
Conditions: Lung Cancer
Keywords: recurrent small cell lung cancer
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 37 participants (actual)
Lead sponsor: Eastern Cooperative Oncology GroupResearch network
Collaborators: National Cancer Institute (NCI)
Study start: 26 May 2004 (actual)
Primary completion: May 2011 (actual)
Study completion: Aug 2012 (actual)
First posted: 6 Jun 2003 (estimated)
Results: Posted 4 Jan 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

Detailed description

OBJECTIVES:

Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
Determine the toxic effects of this regimen in these patients.
Determine the duration of survival in patients treated with this regimen.
Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
IFN-alpha, 13-CRA, paclitaxel	Experimental	Biological: interferon alpha, Drug: 13-cis-retinoic acid, Drug: paclitaxelInterferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (11 listed)

Histologically or cytologically confirmed recurrent small cell lung cancer (SCLC) with clinically confirmed measurable disease
Age 18 and over
ECOG Performance status 0-3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3

Key exclusion criteria (8 listed)

History of another neoplasm other than SCLC except for non-metastatic, non-melanoma skin cancers, carcinoma in situ of the cervix, or cancer cured by surgery or small field radiotherapy at least 5 years before registration
Pregnant or nursing, with a negative pregnancy test within 2 weeks prior to registration
Severe depression requiring medication
Use of the following drugs within 4 weeks prior to registration: carbamazepine, ethanol, tetracycline, doxycycline, minocycline, topical acne products containing Retin-A, vitamin A, cisplatin, ketoconazole, phenytoin or other antiepileptic drugs
Use of GM-CSF or G-CSF within 4 weeks prior to registration

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
interferon alphaAlso: Interferon Alpha-2b, Intron-A, IFN-alpha 2b, NSC# 377523Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.	Biological	IFN-alpha, 13-CRA, paclitaxel
13-cis-retinoic acidAlso: Isotretinoin, RO-43,780, Accutane, Cistane13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.	Drug	IFN-alpha, 13-CRA, paclitaxel
paclitaxelAlso: Taxol, NSC #125973paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.	Drug	IFN-alpha, 13-CRA, paclitaxel

Primary outcome

Response by RECIST Criteria (v 1.0)
Time frame: Assessed every 6 weeks
Number of eligible, treated participants in each response category by RECIST criteria

2 secondary outcomes

Survival
Time frame: Assessed every 3 months for 1 year then every 6 months
Progression-free Survival
Time frame: Assessed every 6 weeks

Results and safety

Results posted to the registry on 4 Jan 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
IFN Alpha, 13-Cis-RA, Paclitaxel	37	34

Primary outcome: Response by RECIST Criteria (v 1.0)

Time frame: Assessed every 6 weeks. Number. Unit: participants

Measure	IFN 13CRA Paclitaxel n = 34
Partial Response	3
Stable Disease	5
Progressive Disease	11
Unevaluable	15

IFN 13CRA Paclitaxel: Overall Response Percentage: 8.8 (90% CI 2.4 to 21.3)

Population analysed: Eligible, treated patients

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Assessed weekly during treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
IFN Alpha, 13-CRA, Paclitaxel	21 of 34 (61.8%)	33 of 34 (97.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lung Cancer

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RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
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RecruitingPhase 3
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)
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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.

Joseph Aisner, MD study chair

Rutgers Cancer Institute of New Jersey

73 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing interferon alpha, 13-cis-retinoic acid and paclitaxel in people with Lung Cancer, run by Eastern Cooperative Oncology Group at 73 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?

The sponsor lists 11 inclusion and 8 exclusion criteria. 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 7 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 73 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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.

What does the primary outcome measure?

Response by RECIST Criteria (v 1.0) (time frame: Assessed every 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00062010.

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 7 Jul 2023.