Lung CancerPhase 2NCT00114192
Docetaxel and Thalidomide as Second-Line Therapy in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer
A Phase 2 study testing docetaxel and thalidomide in people with Lung Cancer, run by University of Virginia at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. 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?
- docetaxel and thalidomide
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2004to Jun 2007
- 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:
- Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of the following stage criteria:
- Stage IIIB (with pleural effusion)
- Stage IIIA or IIIB
- Previously treated and not eligible for surgery or definitive thoracic radiotherapy
- Stage IV
- Measurable or evaluable disease
- Documented disease progression during or after standard first-line chemotherapy that may have included taxane
- No untreated brain metastases
- Patients with previously treated brain metastases are eligible provided they have recovered from prior treatment
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-2
Life expectancy
- Not specified
Hematopoietic
- Absolute neutrophil count > 1,500/mm^3
- Hemoglobin ≥ 8.0 g/dL
- Platelet count > 100,000/mm^3
Hepatic
- Bilirubin normal
- SGOT and/or SGPT ≤ 2.5 times upper limit of normal (ULN) AND alkaline phosphatase normal OR
- SGOT and/or SGPT normal AND alkaline phosphatase ≤ 4 times ULN AND no ascites
- Albumin > 3.0 g/dL
Renal
- Creatinine < 1.5 mg/dL
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective double-method contraception for 4 weeks before, during, and for ≥ 4 weeks after completion of study treatment
- No HIV positivity
- No peripheral neuropathy > grade 1
- No other malignancy within the past 5 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix or breast
- No active infections
- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- See Disease Characteristics
- No more than 1 prior systemic chemotherapy regimen for locally advanced or metastatic disease
- Prior neoadjuvant or adjuvant systemic chemotherapy allowed
- At least 4 weeks since prior chemotherapy and recovered
Endocrine therapy
- Not specified
Radiotherapy
- Recovered from prior radiotherapy
Surgery
- Not specified
Other
- No other concurrent investigational agents
- No other concurrent anticancer therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Cancer Center
Charlottesville, Virginia, 22908
About this study
Official title: Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with stage III or IV non-small cell lung cancer treated with docetaxel and thalidomide as second-line therapy.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the response duration and survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses of treatment may continue study treatment at the discretion of the investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with thalidomide at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and then every 3 months thereafter.
After completion of study treatment, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- docetaxel, thalidomide
- Keywords
- recurrent non-small cell lung cancer, stage IIIA 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.
docetaxelDrug
thalidomideDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete and partial response rates
Secondary outcomes (4)
Toxicity
Response duration
Survival
Quality of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2005 (estimated)
- Study startJun 2004
- Primary completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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 2
- Primary purpose
- Treatment
- Masking
- None (open label)
- Enrolment
- 37 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Heidi Gillenwater, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00114192
- Sponsor's protocol ID
- 11212
- Other IDs
- UVACC-HIC-11212, UVACC-LUNG3, UVACC-29403
- Status last verified
- Jan 2010
- First submitted
- 13 Jun 2005
- Last updated
- 1 Feb 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Docetaxel and Thalidomide as a Second-Line Treatment for Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00114192
- Acronym / sponsor ID
- 11212
- Conditions
- Lung Cancer
- Keywords
- recurrent non-small cell lung cancer, stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jun 2004
- Primary completion
- Jun 2007 (actual)
- First posted
- 14 Jun 2005 (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, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Thalidomide may stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Thalidomide may also help docetaxel work better by making tumor cells more sensitive to the drug. Giving docetaxel together with thalidomide may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with thalidomide works as second-line therapy in treating patients with stage III or stage IV non-small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the complete and partial response rates in patients with stage III or IV non-small cell lung cancer treated with docetaxel and thalidomide as second-line therapy.
Secondary
- Determine the toxicity of this regimen in these patients.
- Determine the response duration and survival of patients treated with this regimen.
- Determine the quality of life of patients treated with this regimen.
OUTLINE: This is an open-label study.
Patients receive docetaxel IV over 30-60 minutes on days 1, 8, and 15. Patients also receive oral thalidomide once daily on days -7 to 28 for course 1 and on days 1-28 for all subsequent courses. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease after 6 courses of treatment may continue study treatment at the discretion of the investigator. Patients discontinuing docetaxel due to toxicity may continue treatment with thalidomide at the discretion of the investigator.
Quality of life is assessed at baseline, before each treatment course, after completion of study treatment, and then every 3 months thereafter.
After completion of study treatment, patients are followed every 3 months for survival.
PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
Study design
- Primary purpose
- Treatment
- 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 |
|---|---|---|
| docetaxel | Drug | – |
| thalidomide | Drug | – |
Primary outcome
Complete and partial response rates
4 secondary outcomes
Toxicity
Response duration
Survival
Quality of life
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 1 Feb 2010.
Related trials for Lung Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
RecruitingObservational study
A Prospective ,Multicenter ,Non-interventional ,Real-world Study Observing Changes in Molecular Markers Osimertinib Targeted Therapy in EGFRm NSCLC
Non Small Cell Lung Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
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)
Non-Small Cell Lung Cancer (NSCLC)
Active, not recruitingPhase 2
Datopotamab Deruxtecan (Dato-DXd, DS-1062a) in Advanced and/or Unresectable Non-Small Cell Lung Cancer
Metastatic Lung Cancer, Advanced Non Small Cell Lung Cancer
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.
Heidi Gillenwater, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing docetaxel and thalidomide in people with Lung Cancer, run by University of Virginia at 1 site 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 1 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Complete and partial response rates. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2010.