Mediastinal NeoplasmsPhase 2NCT00315211
Weekly Topotecan With Docetaxel in Recurrent Small Cell Lung Cancer
A Phase 2 study testing Intravenous Topotecan and Intravenous Docetaxel in people with Mediastinal Neoplasms, run by Aultman Health Foundation at 1 site in United States.
Trial summary
The purposes of this study are: To determine the overall response rate of patients treated with at least 2 cycles of this regimen. To determine the feasibility and toxicity of the combination of topotecan and docetaxel. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mediastinal Neoplasms
- What is being tested?
- Intravenous Topotecan and Intravenous Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2004to 8 Nov 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
Who may be able to join
- Recurred greater than 90 days after initial treatment
- At least 1 measurable lesion
- Only 1 prior chemotherapy
- Must be over 18 years of age
- ECOG performance status of 0 - 2
- Adequate hematologic, renal, and hepatic function
Who cannot join
- No prior use of topotecan, docetaxel, or irinotecan
- No symptomatic brain metastases
- History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
- No prior investigational agents within 1 month prior
- Lung cancer of mixed histology
- Known uncontrolled seizure disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
The purposes of this study are:
- To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
- To determine the feasibility and toxicity of the combination of topotecan and docetaxel.
Read the detailed description
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.
Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.
- Conditions
- Mediastinal Neoplasms
- Being tested
- Intravenous Topotecan, Intravenous Docetaxel
- Keywords
- Small Cell Lung Cancer Recurrent
- Medical subject headings
- Mediastinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous TopotecanDrug
Also called Hycamtin
Topotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days
Intravenous DocetaxelDrug
Also called Taxotere
Docetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle
| Study group | Role | What they receive |
|---|---|---|
| Arm A | Other | Weekly intravenous topotecan with intravenous docetaxel Receives: Drug: Intravenous Topotecan; Drug: Intravenous Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2006 (estimated)
- Study startNov 2004
- Primary completionJun 2007
- Study completion8 Nov 2007
Why it stopped: Slow Accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mediastinal NeoplasmsStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aultman Health Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Sponsor
- Investigators
- Raza Khan, MD, Principal investigator, Aultman Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00315211
- Sponsor's protocol ID
- Hycamtin study #102143
- Other IDs
- Lung 01
- Status last verified
- Aug 2018
- First submitted
- 17 Apr 2006
- Last updated
- 20 Aug 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 Study of Weekly Topotecan With Docetaxel for Recurrent Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT00315211
- Acronym / sponsor ID
- Hycamtin study #102143
- Conditions
- Mediastinal Neoplasms
- Keywords
- Small Cell Lung Cancer Recurrent
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow Accrual
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Aultman Health FoundationUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Nov 2004
- Primary completion
- Jun 2007 (actual)
- Study completion
- 8 Nov 2007 (actual)
- First posted
- 18 Apr 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.
The purposes of this study are:
- To determine the overall response rate of patients treated with at least 2 cycles of this regimen.
- To determine the feasibility and toxicity of the combination of topotecan and docetaxel.
Detailed description
The main objective of this study was to determine the overall response rate of patients treated with at least 2 cycles of topotecan and docetaxel. The secondary objectives were to determine the feasibility and toxicities of this combination. The final secondary objective is overall survival for patients that received 2 or more cycles.
Methods: Eligible pts with recurrent small cell lung cancer had to be at least 3 months from initial treatment. Pts received Docetaxel 30 mg/m2 IV followed by Topotecan 3 mg/m2 IV Days 1 and 8 of a 21 day cycle. Disease assessment was done every 2 cycles. Toxicity was measured each cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm A | Other | Drug: Intravenous Topotecan, Drug: Intravenous DocetaxelWeekly intravenous topotecan with intravenous docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Recurred greater than 90 days after initial treatment
- At least 1 measurable lesion
- Only 1 prior chemotherapy
- Must be over 18 years of age
- ECOG performance status of 0 - 2
Key exclusion criteria (6 listed)
- No prior use of topotecan, docetaxel, or irinotecan
- No symptomatic brain metastases
- History of cardiac arrhythmias, congestive heart failure, stroke, or embolic events
- No prior investigational agents within 1 month prior
- Lung cancer of mixed histology
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 |
|---|---|---|
| Intravenous TopotecanAlso: HycamtinTopotecan 3 mg/m2 IV over 30 minutes on Days 1 and 8 every 21 days | Drug | Arm A |
| Intravenous DocetaxelAlso: TaxotereDocetaxel 30 mg/m2 IV over 60 minutes on Days 1 \& 8 of a 21 day cycle | Drug | Arm A |
Primary outcome
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Time frame: 3 years
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel
Results and safety
The study was stopped early (reason given: Slow Accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Related trials for Mediastinal Neoplasms
Active, not recruitingPhase 1/2
First-in-Human (FIH) Trial in Patients With Relapsed, Progressive or Refractory B-Cell Lymphoma
DLBCL, High-grade B-cell Lymphoma (HGBCL)
Active, not recruitingPhase 1/2
Trial of the Safety and Efficacy of Epcoritamab in Japanese Subjects With Relapsed or Refractory (R/R) B-Cell Non-Hodgkin Lymphoma (R/R B-NHL)
Diffuse Large B Cell Lymphoma, High-grade B-cell Lymphoma
RecruitingPhase 2
A Study of Targeted Post-Surgery Radiation Therapy for Non-Small Cell Lung Cancer With Remaining Lymph Node Cancer After Treatment
Lung Non-Small Cell Carcinoma
Active, not recruitingPhase 1
Pembrolizumab and Vorinostat in Patients With Relapsed or Refractory DLBCL, FCL or HL.
Grade 3b Follicular Lymphoma, Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between DLBCL and Classic HL
RecruitingPhase 2
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Large B-cell Lymphoma
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.
Raza Khan, MD principal investigator
Aultman Hospital
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 Intravenous Topotecan and Intravenous Docetaxel in people with Mediastinal Neoplasms, run by Aultman Health Foundation 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?
The sponsor lists 6 inclusion and 6 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: stopped early, as of the sponsor's last update on 20 Aug 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 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 was stopped early (reason given: Slow Accrual). Results are not available in the source record.
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?
To determine the overall response rate of patients treated with at least two cycles of topotecan and docetaxel (time frame: 3 years). 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 20 Aug 2018.