Non-small Cell Lung CancerPhase 2NCT01038752
Evaluation of Non-cytotoxic Suramin as a Chemosensitizer in Non-small Cell Lung Cancer
A Phase 2 study testing Suramin Drug:Docetaxel Drug: Carboplatin in people with Non-small Cell Lung Cancer, run by Optimum Therapeutics, LLC at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- What is being tested?
- Suramin Drug:Docetaxel Drug: Carboplatin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to May 2013
- 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
- Histologically or cytologically proven on-small cell lung cancer (NSCLC), including squamous cell carcinoma.
- Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
- Known central nervous system metastases if patients are asymptomatic and have completed whole brain or stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to starting treatment on this protocol. Must be off dexamethasone at the time of starting treatment.
- Must have completed radiotherapy at least two weeks prior to registration. Prior radiation therapy is eligible if patient has a measurable lesion that has not been irradiated.
- Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (RECIST criteria).
- Lesions that are not considered measurable include the following:
Show all 23Show fewer
- Bone lesions
- Leptomeningeal disease
- Ascites
- Pleural/pericardial effusion
- Abdominal masses that are not confirmed and followed by imaging techniques
- Cystic lesions
- Tumor lesions situated in a previously irradiated area
- ECOG performance status of 0-1.
- Life expectancy ≥ 3 months.
- Adequate bone marrow function, absolute neutrophil count ≥1,500/mm3, hemoglobin ≥9.9 gm/dl, and platelet count ≥100,000/mm3.
- Adequate liver function defined as bilirubin ≤ 1x upper level of the institutional normal (ULIN). AST and ALT and Alkaline Phosphatase must be within the range allowing for eligibility. In determining eligibility the more abnormal of the two values (AST or ALT) should be used. See protocol.
- Must have adequate renal function defined as serum creatinine ≤ 2.0 mg/dl or calculated creatinine clearance ≥ 60 ml/min for patients with creatinine levels above 2.0 mg/dl.
- Must have recovered from uncontrolled intercurrent illness, including ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia.
- Use of adequate contraception (hormonal or barrier method of birth control) for the duration of study participation and continued for at least three months after completing treatment. Non-pregnant status will be determined in all women of childbearing potential.
- Age > 18.
- Patients must have given written informed consent.
- Entry to this study is open to both men and women and to all racial and ethnic subgroups. The goal is to accrue a minimum of 44 patients of African-American ancestry and a maximum of 120 non-African-American patients. Classification of patient race and ancestry will be based on patient's self-identification on the consent form for the clinical trial.
Who cannot join
- History of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
- Grade 3 or 4 neuropathy.
- Women who are pregnant or breast-feeding.
- Prior chemotherapy or biologic therapy (e.g., erlotinib) for NSCLC including neoadjuvant or adjuvant chemotherapy.
- Currently active second malignancy other than non-melanoma skin cancer. Currently active malignancy does not include prior malignancy treated with therapy and considered to have less than 30% risk of relapse.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
John H Stroger Jr Hospital of Cook County
Chicago, Illinois, 60612
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia, 23298
About this study
Official title: Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive Non-small Cell Lung Cancer (NSCLC): A Randomized Single-Blind Placebo-Controlled Phase II Study
The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.
Read the detailed description
The primary objective is to determine the progression free survival for patients with stage III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and carboplatin with or without suramin.
The secondary objectives are to compare median overall survival rate, compare overall response rate of patients in both arms, assess toxicity of suramin with docetaxel and carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to determine whether survival benefit from suramin is associated with M phase entry in peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and carboplatin produces greater survival benefits in African-American patients.
- Conditions
- Non-small Cell Lung Cancer
- Being tested
- Suramin Drug:Docetaxel Drug: Carboplatin, Placebo Drug: Docetaxel Drug: Carboplatin
- Keywords
- NSCLC, suramin, lung cancer, chemotherapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suramin Drug:Docetaxel Drug: CarboplatinDrug
Also called CI-1003, PD 002927-0015F, NSC 34936, Bayer 205
Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
Placebo Drug: Docetaxel Drug: CarboplatinDrug
Also called Taxotere, Paraplatin
Placebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour).
| Study group | Role | What they receive |
|---|---|---|
| Suramin | Experimental | This group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. Receives: Drug: Suramin Drug:Docetaxel Drug: Carboplatin |
| Standard of care | Placebo comparator | This group will receive placebo with docetaxel and carboplatin. Receives: Drug: Placebo Drug: Docetaxel Drug: Carboplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria
Insufficient data
Measured: Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.
Secondary outcomes (7)
Overall Survival of Participants
Insufficient Data
Measured: First treatment date to date of death
Overall Response Rate (Complete Response + Partial Response) of Participants
Insufficient data
Measured: Tumor assessment at every other cycle
Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.
Insufficient data.
Measured: Day 1 of each cycle; end of treatment visit; at follow-up.
Pre-treatment bFGF Levels Correlation With Survival.
Insufficient data.
Measured: Before first treatment
Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes
Insufficient data.
Measured: Randomization date
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.
Insufficient data.
Measured: Randomization date to date of death
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.
Insufficient data.
Measured: Randomization date to date of death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2009 (estimated)
- Study startAug 2010
- Primary completionNov 2012
- Study completionMay 2013
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 Non-small Cell 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optimum Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01038752
- Sponsor's protocol ID
- Optimum-Suramin-1
- Status last verified
- May 2015
- First submitted
- 22 Dec 2009
- Last updated
- 21 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination of Non-Cytotoxic Suramin With Docetaxel and Carboplatin in Chemo-Naive Non-small Cell Lung Cancer (NSCLC): A Randomized Single-Blind Placebo-Controlled Phase II Study
- ClinicalTrials.gov ID
- NCT01038752
- Acronym / sponsor ID
- Optimum-Suramin-1
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- NSCLC, suramin, lung cancer, chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Optimum Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 24 Dec 2009 (estimated)
- Results
- Posted 21 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the benefit of adding suramin at a non-cytotoxic dose to carboplatin and docetaxel regimen in the treatment of chemo-naïve patients with non-small cell lung cancer.
Detailed description
The primary objective is to determine the progression free survival for patients with stage III B with malignant pleural effusion or Stage IV NSCLC treated with docetaxel and carboplatin with or without suramin.
The secondary objectives are to compare median overall survival rate, compare overall response rate of patients in both arms, assess toxicity of suramin with docetaxel and carboplatin, determine whether pre-treatment bFGF levels correlate with survival, to determine whether survival benefit from suramin is associated with M phase entry in peripheral blood lymphocytes, and to determine whether adding suramin to docetaxel and carboplatin produces greater survival benefits in African-American patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Suramin | Experimental | Drug: Suramin Drug:Docetaxel Drug: CarboplatinThis group will receive the combination of non-cytotoxic suramin with docetaxel and carboplatin. |
| Standard of care | Placebo comparator | Drug: Placebo Drug: Docetaxel Drug: CarboplatinThis group will receive placebo with docetaxel and carboplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Histologically or cytologically proven on-small cell lung cancer (NSCLC), including squamous cell carcinoma.
- Newly-diagnosed stage IIIB with malignant pleural effusion, stage IV or recurrent disease.
- Known central nervous system metastases if patients are asymptomatic and have completed whole brain or stereotactic radiation at least 2 weeks prior or surgery at least 4 weeks prior to starting treatment on this protocol. Must be off dexamethasone at the time of starting treatment.
- Must have completed radiotherapy at least two weeks prior to registration. Prior radiation therapy is eligible if patient has a measurable lesion that has not been irradiated.
- Must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (RECIST criteria).
Key exclusion criteria (5 listed)
- History of severe hypersensitivity reaction to Docetaxel or other drugs formulated with polysorbate 80.
- Grade 3 or 4 neuropathy.
- Women who are pregnant or breast-feeding.
- Prior chemotherapy or biologic therapy (e.g., erlotinib) for NSCLC including neoadjuvant or adjuvant chemotherapy.
- Currently active second malignancy other than non-melanoma skin cancer. Currently active malignancy does not include prior malignancy treated with therapy and considered to have less than 30% risk of relapse.
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 |
|---|---|---|
| Suramin Drug:Docetaxel Drug: CarboplatinAlso: CI-1003, PD 002927-0015F, NSC 34936, Bayer 205Suramin dosage will be determined by nomogram and administered over 30 minutes. Suramin is followed by docetaxel (56 mg/m2, administered over 1 hour), followed by carboplatin (dosage calculated by Calvert equation to have a target AUC of 6, administered over 1 hour). | Drug | Suramin |
| Placebo Drug: Docetaxel Drug: CarboplatinAlso: Taxotere, ParaplatinPlacebo (100 ml of 0.9% sodium chloride or 5% dextrose in water) will be administered over 30 minutes, followed by docetaxel (75 mg/m2, administered over 1 hour), followed by carboplatin (dose calculated by Calvert equation to have a target AUC of 6, administered over 1 hour). | Drug | Standard of care |
Primary outcome
Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria
Time frame: Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.
Insufficient data
7 secondary outcomes
Overall Survival of Participants
Time frame: First treatment date to date of death
Overall Response Rate (Complete Response + Partial Response) of Participants
Time frame: Tumor assessment at every other cycle
Toxicity of Combination of Non-cytotoxic Suramin With Docetaxel and Carboplatin.
Time frame: Day 1 of each cycle; end of treatment visit; at follow-up.
Pre-treatment bFGF Levels Correlation With Survival.
Time frame: Before first treatment
Survival Benefit From Non-cytotoxic Suramin Association With Reduced M-phase Entry in Peripheral Blood Lymphocytes
Time frame: Randomization date
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Survival Benefits in African-American Patients.
Time frame: Randomization date to date of death
To Determine Whether Adding Non-cytotoxic Suramin to Docetaxel and Carboplatin Produces Greater Survival Benefits in African-American Patients Compared to Non-African-American Patients.
Time frame: Randomization date to date of death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Suramin Drug:Docetaxel Drug: Carboplatin in people with Non-small Cell Lung Cancer, run by Optimum Therapeutics, LLC 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 23 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: stopped early, as of the sponsor's last update on 21 May 2015. 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. Some participants in this study may receive a placebo. 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 21 Oct 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?
Progression-free Survival for Participants With Stage IIIB/IV NSCLC Per RECIST Criteria (time frame: Patients will be followed every 2 months for the first 6 months following the last cycle of treatment, every three months for the next year, and every 6 months thereafter.). 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 21 May 2015.