Lung CancerPhase 2NCT00053300
Thalidomide in Treating Patients With Extensive-Stage Small Cell Lung Cancer
A Phase 2 study testing thalidomide and adjuvant therapy in people with Lung Cancer, run by Case Comprehensive Cancer Center at 2 sites in United States.
Trial summary
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor. PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- thalidomide and adjuvant therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2002to Apr 2010
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
DISEASE CHARACTERISTICS:
- Diagnosis of extensive-stage small cell lung cancer
- Complete or partial response after 4-6 courses of induction chemotherapy
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- At least 2 months
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use 2 effective methods of contraception for at least 4 weeks before, during, and for at least 4 weeks after study
- No greater than grade 1 peripheral neuropathy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
About this study
Official title: Phase II Trial of Daily Thalidomide in Extensive Stage Small Cell Lung Cancer Patients Achieving a Complete or Partial Response to Induction Chemotherapy
RATIONALE: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.
Read the detailed description
OBJECTIVES:
- Determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within approximately 18 months.
- Conditions
- Lung Cancer
- Being tested
- thalidomide, adjuvant therapy
- Keywords
- extensive stage small cell lung cancer
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thalidomideDrug
oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
adjuvant therapyProcedure or surgery
Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease response
Measured: every 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2003 (estimated)
- Study startAug 2002
- Primary completionNov 2005
- Study completionApr 2010
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.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Afshin Dowlati, MD, Study chair, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00053300
- Sponsor's protocol ID
- CWRU1502
- Other IDs
- P30CA043703, CASE-CWRU-1502, CELGENE-CWRU-1502, CASE-1502
- Status last verified
- Jun 2010
- First submitted
- 27 Jan 2003
- Last updated
- 10 Jun 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cooney MM, Subbiah S, Chapman R, et al.: Phase II trial of maintenance daily oral thalidomide in patients with extensive-stage small cell lung cancer (ES-SCLC) in remission. [Abstract] J Clin Oncol 23 (Suppl 16): A-7166, 661s, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Trial of Daily Thalidomide in Extensive Stage Small Cell Lung Cancer Patients Achieving a Complete or Partial Response to Induction Chemotherapy
- ClinicalTrials.gov ID
- NCT00053300
- Acronym / sponsor ID
- CWRU1502
- Conditions
- Lung Cancer
- Keywords
- extensive stage small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Aug 2002
- Primary completion
- Nov 2005 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 28 Jan 2003 (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: Thalidomide may stop the growth of cancer by stopping blood flow to the tumor.
PURPOSE: Phase II trial to study the effectiveness of thalidomide in treating patients who have extensive-stage small cell lung cancer that has responded to previous chemotherapy.
Detailed description
OBJECTIVES:
- Determine the effect of thalidomide on time to disease progression and survival in patients with extensive-stage small cell lung cancer who achieve a complete or partial response to induction chemotherapy.
- Determine the toxicity of this drug in these patients.
OUTLINE: This is an open-label study.
Patients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study within approximately 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| thalidomideoral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity | Drug | – |
| adjuvant therapyPatients receive oral thalidomide daily beginning 3-4 weeks after completion of induction chemotherapy. Treatment continues for 1 year in the absence of disease progression or unacceptable toxicity. | Procedure or surgery | – |
Primary outcome
Disease response
Time frame: every 12 weeks
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 10 Jun 2010.
- Results publicationCooney MM, Subbiah S, Chapman R, et al.: Phase II trial of maintenance daily oral thalidomide in patients with extensive-stage small cell lung cancer (ES-SCLC) in remission. [Abstract] J Clin Oncol 23 (Suppl 16): A-7166, 661s, 2005.
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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.
Afshin Dowlati, MD study chair
Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
2 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 thalidomide and adjuvant therapy in people with Lung Cancer, run by Case Comprehensive Cancer Center 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 10 Jun 2010. 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 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?
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.
What does the primary outcome measure?
Disease response (time frame: every 12 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 NCT00053300, 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 10 Jun 2010.