Carcinoma, Non Small Cell LungPhase 2NCT01671332
Docetaxel +/- Suramin in 2nd Line Advanced Non-Small Cell Lung Cancer
A Phase 2 study testing Docetaxel and Suramin in people with Carcinoma, Non Small Cell Lung, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non Small Cell Lung
- What is being tested?
- Docetaxel and Suramin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jun 2012to 16 Jun 2016
- 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
Who may be able to join
- Pathologically proven diagnosis of non-small cell lung cancer
- Documented disease progression after first-line chemotherapy for non-small cell lung cancer
- Stable and treated CNS metastasis is allowed
- Radiation must be completed at least 2 weeks prior to starting protocol treatment
- Major surgery must be completed at least 4 weeks prior to starting protocol treatment
- ECOG performance status 0-2
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- Sexually active patients must use adequate contraception
- Adequate bone marrow function
- Adequate renal function
- Adequate liver function
Who cannot join
- Severe hypersensitivity reaction to docetaxel
- Pre-existing grade 3 or 4 neuropathy
- Women who are pregnant or breastfeeding
- Uncontrolled intercurrent illness
- Receipt of 3 or more prior chemotherapy regimens
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Carbone Comprehensive Cancer Center
Madison, Wisconsin, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin
About this study
Official title: Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Read the detailed description
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Secondary objectives include:
- To compare response rate of patients in both treatment arms
- To compare overall survival of patients in both treatment arms
- To compare toxicity in both treatment arms
- To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes
- Conditions
- Carcinoma, Non Small Cell Lung
- Being tested
- Docetaxel, Suramin
- Keywords
- Carcinoma, non small cell lung, Second line, Third line
- Medical subject headings
- 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
Also called Taxotere
IV over 60 minutes, 75 mg/m2
SuraminDrug
IV over 30 minutes
DocetaxelDrug
Also called Taxotere
IV over 60 minutes. 56 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| Docetaxel | Active comparator | Not described Receives: Drug: Docetaxel |
| Docetaxel plus Suramin | Experimental | Not described Receives: Drug: Suramin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival in Months
Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.
Measured: Up to 1 year
Secondary outcomes (4)
Response Rate Per RECIST 1.1 Criteria
Response rate per RECIST 1.1, as follows:
Complete response (CR): Disappearance of all extranodal target lesions. All pathological lymph nodes must have decreased to <10 mm in short axis Partial response (PR): At least 30% decrease in the sum of longest diameters (SLD) of target lesions, taking as reference the baseline sum diameters Progressive disease (PD): SLD increased by at least 20% from the smallest value on study (including baseline, if that is smallest). The SLD must also demonstrate an absolute increase of at least 5 mm. (Two lesions increasing from 2mm to 3mm, for example, does not qualify).
Stable disease (SD): Neither sufficient shrinkage to qualify for PR not sufficient increase to qualify for PD
Measured: Up to 1 year
Overall Survival
Compare overall survival of participants in both treatment arms.
Measured: Up to 50 months
Number of Participants With Toxicity/Adverse Events From Treatment
The investigators will compare the toxicity profiles of the two arms of therapy to determine if the docetaxel + suramin has a more favorable toxicity profile than docetaxel alone. This count includes only adverse events considered definitely, probably, or possibly due to treatment.
Measured: Up to 2 years
Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.
The investigators hypothesize that suramin in combination with docetaxel improves response rates and survival by increasing the cancer cell population in the M phase of the cell cycle. The G2-M checkpoint control score, defined as (%M-phase arrested cells after cisplatin+suramin)/(%M-phase arrested cells after cisplatin), is an indicator of the effect of suramin on cell accumulation in the M-phase. G2-M checkpoint control was evaluated as a predictor of PFS and OS in participant receiving suramin by linear correlation.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2012 (estimated)
- Study startJun 2012
- Primary completion11 Jun 2015
- Study completion16 Jun 2016
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 Carcinoma, Non Small Cell LungStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Medical College of Wisconsin, Optimum Therapeutics, LLC, Ohio State University
- Responsible party
- Sponsor
- Investigators
- Anne M Traynor, MD, Principal investigator, University of Wisconsin, MadisonRafael Santana-Davila, MD, Study chair, Medical College of Wisconsin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01671332
- Sponsor's protocol ID
- CO11508
- Other IDs
- A534260, SMPH/MEDICINE/MEDICINE*H, 2012-0118, NCI-2012-01113
- Status last verified
- May 2020
- First submitted
- 25 Jun 2012
- Last updated
- 12 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Phase II Study of Suramin and Docetaxel Versus Docetaxel in Non-Small Cell Lung Cancer After Failure of First-Line Chemotherapy
- ClinicalTrials.gov ID
- NCT01671332
- Acronym / sponsor ID
- CO11508
- Conditions
- Carcinoma, Non Small Cell Lung
- Keywords
- Carcinoma, non small cell lung, Second line, Third line
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Medical College of Wisconsin, Optimum Therapeutics, LLC, Ohio State University
- Study start
- Jun 2012 (actual)
- Primary completion
- 11 Jun 2015 (actual)
- Study completion
- 16 Jun 2016 (actual)
- First posted
- 23 Aug 2012 (estimated)
- Results
- Posted 12 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Detailed description
The overall purpose of the study is to determine whether or not the inclusion of suramin to standard treatment with docetaxel improves progression-free survival for patients with advanced non-small cell lung cancer in the second and third line settings.
Secondary objectives include:
- To compare response rate of patients in both treatment arms
- To compare overall survival of patients in both treatment arms
- To compare toxicity in both treatment arms
- To determine whether the survival benefit from suramin is associated with reduced M-phase entry in peripheral blood lymphocytes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Docetaxel | Active comparator | Drug: Docetaxel |
| Docetaxel plus Suramin | Experimental | Drug: Suramin, Drug: Docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Pathologically proven diagnosis of non-small cell lung cancer
- Documented disease progression after first-line chemotherapy for non-small cell lung cancer
- Stable and treated CNS metastasis is allowed
- Radiation must be completed at least 2 weeks prior to starting protocol treatment
- Major surgery must be completed at least 4 weeks prior to starting protocol treatment
Key exclusion criteria (5 listed)
- Severe hypersensitivity reaction to docetaxel
- Pre-existing grade 3 or 4 neuropathy
- Women who are pregnant or breastfeeding
- Uncontrolled intercurrent illness
- Receipt of 3 or more prior chemotherapy regimens
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 |
|---|---|---|
| DocetaxelAlso: TaxotereIV over 60 minutes, 75 mg/m2 | Drug | Docetaxel |
| SuraminIV over 30 minutes | Drug | Docetaxel plus Suramin |
| DocetaxelAlso: TaxotereIV over 60 minutes. 56 mg/m2 | Drug | Docetaxel plus Suramin |
Primary outcome
Progression-free Survival in Months
Time frame: Up to 1 year
Compare progression-free survival (PFS) in participants with advanced NSCLC treated with docetaxel with or without suramin after failure of first-line chemotherapy. PFS is defined as the duration of time from the time of randomization to time of disease progression or death, whichever occurs first.
4 secondary outcomes
Response Rate Per RECIST 1.1 Criteria
Time frame: Up to 1 year
Overall Survival
Time frame: Up to 50 months
Number of Participants With Toxicity/Adverse Events From Treatment
Time frame: Up to 2 years
Evaluation of Peripheral Blood Lymphocytes for DNA Damage-induced Checkpoint Control.
Time frame: Baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
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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.
Anne M Traynor, MD principal investigator
University of Wisconsin, Madison
Rafael Santana-Davila, MD study chair
Medical College of Wisconsin
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 Docetaxel and Suramin in people with Carcinoma, Non Small Cell Lung, run by University of Wisconsin, Madison 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?
The sponsor lists 10 inclusion and 5 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: finished, as of the sponsor's last update on 12 May 2020. 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?
Yes. Results are posted in the registry (first posted 12 May 2020). 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?
Progression-free Survival in Months (time frame: Up to 1 year). 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 May 2020.