Lung CancerPhase 2NCT00984542
Bendamustine as Second-Line Therapy in Treating Patients With Relapsed or Refractory Small Cell Lung Cancer
A Phase 2 study testing bendamustine hydrochloride in people with Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 6 sites in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. 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?
- bendamustine hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 6 sitesUnited States
- Study dates
- Sep 2009to Sep 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
DISEASE CHARACTERISTICS:
- Histologically or cytologically confirmed small cell lung cancer
- Relapsed or refractory disease after 1-2 prior chemotherapy regimens
- Measurable disease
- ECOG - Eastern Cooperative Oncology Group performance status 0-2
- ANC ≥ 1,500/mm³: ANC = Absolute neutrophil count
- Platelet count ≥ 100,000/mm³
- Hemoglobin ≥ 9 g/dL
- Bilirubin normal
- AST/ALT ≤ 2 times upper limit of normal (ULN) (≤ 5 times ULN in patients with hepatic metastases; AST/ALT = alanine transaminase (ALT) and aspartate aminotransferase (AST)
- Creatinine clearance > 40 mL/min
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception before, during, and for ≥ 3 months after completion of study therapy
- No known hypersensitivity to bendamustine
- No other malignancy for which the patient has been treated within the past year except for nonmelanoma skin cancer or carcinoma in situ of the cervix
- No cardiac disease, including any of the following:
- Unstable angina pectoris
- Life-threatening cardiac arrhythmia
- Symptomatic congestive heart failure
- No uncontrolled infection
- No other concurrent chemotherapy, immunotherapy, or anti-tumor hormonal therapy
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Hardin Memorial Hosptial
Elizabethtown, Kentucky, 42701
The Jones Clinic - Germantown
Germantown, Tennessee, 38138
Jackson-Madison County Hospital
Jackson, Tennessee, 38301
Baptist Regional Cancer Center at Baptist Riverside
Knoxville, Tennessee, 37901
Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, 37064
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
About this study
Official title: Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.
Secondary
- To determine the toxicity of this drug in these patients.
- To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-8 weeks.
- Conditions
- Lung Cancer
- Being tested
- bendamustine hydrochloride
- 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.
bendamustine hydrochlorideDrug
Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle
| Study group | Role | What they receive |
|---|---|---|
| Bendamustine | Experimental | Not described Receives: Drug: bendamustine hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Progression
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Measured: On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)
Secondary outcomes (4)
Number of Patients With Each Worst-grade Toxicity
Number of patients with worst-grade toxicity at each of five grades following NCI Common Toxicity Criteria with grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening/disabling, 5 = death.
Measured: Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days
Best Response
Number of patients in each response category, per RECIST v1.1, summarized as follows for target lesion criteria (see RECIST v1.1 for additional details):
complete response (CR),disappearance of target lesions; partial response (PR), >=30% decrease in sum of longest diameter of target lesions; progressive disease (PD), >=20% increase in sum of LD of target lesions or appearance of new lesions; stable disease (SD), insufficient change in target lesions or new lesions to qualify as either PD or SD. Patients are categorized according to the best response achieved prior to occurrence of progressive disease, where best response hierarchy is CR>PR>SD>PD.
Measured: On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)
Progression-free Survival
Estimated probable duration of life without disease progression, from on-study date to earlier of progression date or date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
Measured: On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)
Overall Survival
Estimated probable duration of life from on-study date to date of death from any cause, using the Kaplan-Meier method with censoring (see analysis population description for additional details)
Measured: On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2012
- Study completionSep 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Leora Horn, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Leora Horn, M.D., Principal investigator, Vanderbilt-Ingram Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984542
- Sponsor's protocol ID
- VICC THO 0920
- Other IDs
- P30CA068485, VU-VICC-THO-0920
- Status last verified
- Aug 2013
- First submitted
- 24 Sep 2009
- Last updated
- 12 Mar 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Second-Line Bendamustine in Relapsed or Refractory Small Cell Lung Cancer (SCLC).
- ClinicalTrials.gov ID
- NCT00984542
- Acronym / sponsor ID
- VICC THO 0920
- Conditions
- Lung Cancer
- Keywords
- recurrent small cell lung cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Sep 2009
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Posted 12 Mar 2014
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 bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.
PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.
Detailed description
OBJECTIVES:
Primary
- To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.
Secondary
- To determine the toxicity of this drug in these patients.
- To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.
OUTLINE: This is a multicenter study.
Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up every 6-8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bendamustine | Experimental | Drug: bendamustine hydrochloride |
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 |
|---|---|---|
| bendamustine hydrochlorideBendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle | Drug | Bendamustine |
Primary outcome
Time to Progression
Time frame: On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)
Estimated probable duration from on-study date to date of disease progression, using the Kaplan-Meier method with censoring (see analysis population description for additional details). Disease progression is defined under RECIST v1.1 as >=20% increase in sum of longest diameters of target lesions, unequivocal progression of non-target lesions, or appearance of new lesions.
4 secondary outcomes
Number of Patients With Each Worst-grade Toxicity
Time frame: Day 1 of each 21-day cycle for 6 cycles and at 30 days after end of treatment, at 156 days
Best Response
Time frame: On-treatment date to date of disease progression, following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)
Progression-free Survival
Time frame: On-study date to lesser of date of progression or date of death from any cause ,measured following cycle 2, 4, 6 of a 21-day cycle for 6 cycles, (assessed up to 126 days)
Overall Survival
Time frame: On study to date of death from any cause or last date known alive, measured every 6-8 weeks from the end of treatment, up to 31 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink provided by the sponsor.
Related trials for Lung Cancer
Recruiting
MRD-Guided Postoperative Surveillance and Adaptive Treatment for Resectable Lung Cancer
Lung Neoplasms, Neoadjuvant Therapy
Not yet recruitingPhase 3
Intraarterial Therapies Plus Tislelizumab Plus Lenvatinib Versus Tislelizumab Plus Gemcitabine-Cisplatin in Unresectable Intrahepatic Cholangiocarcinoma
Intrahepatic Cholangiocarcinoma (Icc)
Active, not recruitingPhase 3
A Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB27 and Keytruda in Subjects With Metastatic Non-squamous Non-small Cell Lung Cancer
Non-small Cell Lung Cancer Stage IV
RecruitingObservational study
Label-free Femtosecond Laser Imaging Combined With the Fast Lung Artificial Intelligence Model for Rapid Intraoperative Diagnosis of Lung Surgical Specimens: A Multicentre, Prospective, Parallel-workflow, Non-inferiority Study.
Lung Cancer
RecruitingPhase 3
A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)
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.
Leora Horn, M.D. principal investigator
Vanderbilt-Ingram Cancer Center
6 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 bendamustine hydrochloride in people with Lung Cancer, run by Vanderbilt-Ingram Cancer Center at 6 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 12 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 12 Mar 2014). 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?
Time to Progression (time frame: On-study to date of progression, measured following cycle 2, 4, and 6 of a 21-day cycle for 6 cycles, (during 126 days)). 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 12 Mar 2014; AzTrials last refreshed its copy on 26 Oct 2026.