Lung CancerPhase 1NCT00287963
Topotecan and Vinorelbine in Treating Patients With Recurrent Lung Cancer
A Phase 1 study testing topotecan hydrochloride and vinorelbine tartrate in people with Lung Cancer, run by Medical University of South Carolina at 1 site in United States.
Trial summary
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. 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?
- topotecan hydrochloride and vinorelbine tartrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jan 2010
- Phase
- Phase 1
- 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 lung cancer
- All histologic types eligible
- Recurrent or progressive disease after ≥ 1 prior chemotherapy regimen with or without radiotherapy
PATIENT CHARACTERISTICS:
- ECOG performance status (PS) ≤ 2
- Karnofsky PS ≥ 60%
- Absolute neutrophil count ≥ 1,500/mm^3
- Platelet count ≥ 100,000/mm^3
- Total bilirubin ≤ 1.5 mg/dL
- Creatinine ≤ 1.5 mg/dL
- Not pregnant or nursing
- Fertile patients must use effective contraception
- No other active invasive malignancy
- No uncontrolled illness including, but not limited to:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- No psychiatric illness/social situation that would limit compliance with study requirements
- No history of allergic reactions attributed to compounds of similar chemical or biologic composition to topotecan or vinorelbine ditartrate
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 2 weeks since prior radiotherapy
- No prior therapy with topotecan or vinorelbine ditartrate
- No chemotherapy within the past 4 weeks (6 weeks for nitrosoureas or mitomycin C)
- Recovered from agents administered > 4 weeks earlier
- No other concurrent investigational agents
- No concurrent palliative radiotherapy
- No other concurrent anticancer therapies or agents
- No concurrent hormones or other chemotherapy except for the following:
- Steroids for adrenal failure
- Hormones for nondisease-related conditions (e.g., insulin for diabetes)
- Intermittent dexamethasone as an antiemetic
Trial locations and contacts
1 site in 1 country.
United States1 site
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
About this study
Official title: A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
RATIONALE: Drugs used in chemotherapy, such as topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Read the detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.
Secondary
- Assess the response and stable disease rates and the time to disease progression among treated patients.
OUTLINE: This is a dose-escalation study of topotecan.
Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 patients will be accrued for this study.
- Conditions
- Lung Cancer
- Being tested
- topotecan hydrochloride, vinorelbine tartrate
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, combined type small cell lung cancer, intermediate type small cell lung cancer, large cell lung cancer, lymphocyte-like type small cell lung cancer, recurrent non-small cell lung cancer, recurrent small cell lung cancer, squamous cell lung cancer
- Medical subject headings
- Lung Neoplasms, Adenocarcinoma of Lung, Adenocarcinoma, Bronchiolo-Alveolar, Carcinoma, Non-Small-Cell Lung, Small Cell Lung Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topotecan hydrochlorideDrug
vinorelbine tartrateDrug
| Study group | Role | What they receive |
|---|---|---|
| Vinorelbine + topotecan | Experimental | Not described Receives: Drug: topotecan hydrochloride; Drug: vinorelbine tartrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose
Measured: Cycle 1 (up to day 21)
Secondary outcomes (3)
Response rate
Measured: while on study, at the end of each 3 week cycle
stable disease rate
Measured: while on study, at the end of each 3 week cycle
time to progression
Measured: from start of treatment to day of documented progression or death, whichever comes first, up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2006 (estimated)
- Study startFeb 2004
- Primary completionJan 2010
- Study completionJan 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.
- More trials run by Medical University of South CarolinaThe 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew S. Kraft, MD, Study chair, Medical University of South CarolinaGustavo Leone, Study chair, Medical University of South Carolina, Hollings Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00287963
- Sponsor's protocol ID
- CDR0000454919
- Other IDs
- MUSC-104864/725, GSK-100780
- Status last verified
- May 2018
- First submitted
- 6 Feb 2006
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Beldner MA, Sherman CA, Green MR, Garrett-Mayer E, Chaudhary U, Meyer ML, Kraft AS, Montero AJ. Phase I dose escalation study of vinorelbine and topotecan combination chemotherapy in patients with recurrent lung cancer. BMC Cancer. 2007 Dec 20;7:231. doi: 10.1186/1471-2407-7-231.
PubMed 18096059
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Topotecan in Combination With Vinorelbine in Recurrent Lung Cancer
- ClinicalTrials.gov ID
- NCT00287963
- Acronym / sponsor ID
- CDR0000454919
- Conditions
- Lung Cancer
- Keywords
- adenocarcinoma of the lung, adenosquamous cell lung cancer, bronchoalveolar cell lung cancer, combined type small cell lung cancer, intermediate type small cell lung cancer, large cell lung cancer, lymphocyte-like type small cell lung cancer, recurrent non-small cell lung cancer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 7 Feb 2006 (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 topotecan and vinorelbine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
PURPOSE: This phase I trial is studying the side effects and best dose of topotecan when given together with vinorelbine in treating patients with recurrent lung cancer.
Detailed description
OBJECTIVES:
Primary
- Determine the maximum tolerated dose of topotecan when combined with vinorelbine ditartrate in patients with recurrent lung cancer.
Secondary
- Assess the response and stable disease rates and the time to disease progression among treated patients.
OUTLINE: This is a dose-escalation study of topotecan.
Patents receive vinorelbine ditartrate IV over 8-10 minutes and topotecan IV over 30 minutes on days 1 and 8. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which ≥ 2 of 6 patients experience dose-limiting toxicity.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 36 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 |
|---|---|---|
| Vinorelbine + topotecan | Experimental | Drug: topotecan hydrochloride, Drug: vinorelbine tartrate |
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 |
|---|---|---|
| topotecan hydrochloride | Drug | Vinorelbine + topotecan |
| vinorelbine tartrate | Drug | Vinorelbine + topotecan |
Primary outcome
Maximum tolerated dose
Time frame: Cycle 1 (up to day 21)
3 secondary outcomes
Response rate
Time frame: while on study, at the end of each 3 week cycle
stable disease rate
Time frame: while on study, at the end of each 3 week cycle
time to progression
Time frame: from start of treatment to day of documented progression or death, whichever comes first, up to 36 months
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 17 May 2018.
- Results publication: PubMed 18096059Beldner MA, Sherman CA, Green MR, Garrett-Mayer E, Chaudhary U, Meyer ML, Kraft AS, Montero AJ. Phase I dose escalation study of vinorelbine and topotecan combination chemotherapy in patients with recurrent lung cancer. BMC Cancer. 2007 Dec 20;7:231. doi: 10.1186/1471-2407-7-231.
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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.
Andrew S. Kraft, MD study chair
Medical University of South Carolina
Gustavo Leone study chair
Medical University of South Carolina, Hollings Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topotecan hydrochloride and vinorelbine tartrate in people with Lung Cancer, run by Medical University of South Carolina 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 17 May 2018. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Maximum tolerated dose (time frame: Cycle 1 (up to day 21)). 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 NCT00287963, 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 17 May 2018.