Carcinoma, Non-Small-Cell LungNCT01006226
64CuATSM and Hypoxia in Stage IV Non-small Cell Lung Cancer With Carboplatin, Paclitaxel, and Bevacizumab
A study testing 64Cu-ATSM PET in people with Carcinoma, Non-Small-Cell Lung, run by Washington University School of Medicine.
Trial summary
The purpose of this study is to determine: Whether bevacizumab increases the amount of oxygen in cancer as measured by a special positron emission tomography (PET) scan using 64Cu-ATSM. 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?
- 64Cu-ATSM PET
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Start not givento not given
- Phase
- Interventional
- 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
- Patients must have histologically or cytologically confirmed non-squamous NSCLC.
- Clinically or pathologically proven Stage IV NSCLC.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm irrespective of scanner type.
- No previous chemotherapy.
- Age >18 years.
- Because no dosing or adverse event data are currently available on the use of 64Cu-ATSM in combination with paclitaxel, carboplatin, and bevacizumab in patients <18 years of age, children are excluded from this study but will be eligible for future pediatric phase 2 combination trials.
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- ECOG performance status 0-1.
- Patients must have normal organ and marrow function as defined below:
- hemoglobin >9 gm/dL
- absolute neutrophil count >1,500/mcL
- platelets >100,000/mcL
- total bilirubin < 1.5 mg/dL
- AST(SGOT)/ALT(SGPT) <3 X institutional upper limit of normal
- alkaline phosphatase <3 X institutional upper limit of normal
- creatinine <1.5 X institutional upper limit of normal
- OR
- creatinine clearance >60 mL/min/1.73 m2 (Cockcroft Gault)
- urine dipstick for proteinuria < 1+
- Adequate coagulation function - INR < 1.5 and PTT < institutional upper limit of normal.
- The effects of 64Cu-ATSM on the developing human fetus at the recommended imaging dose are unknown. For this reason and because chemotherapeutic agents as well as other therapeutic agents used in this trial are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
- Ability of the patient to understand and the willingness to sign a written informed consent document.
Who cannot join
- Patients who have had prior chemotherapy.
- Patients who have had prior radiation therapy for lung cancer.
- Patients may not be receiving any other investigational agents.
- Patients with known central nervous system metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-ATSM or other agents used in the study.
- History of claustrophobia, since patients might not be able to tolerate 64CuATSM-PET imaging.
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- History of gross hemoptysis - bright red blood of > ½ teaspoon in quantity - in past 6 months.
- Any concurrent or history of active malignancy in the prior five years except for basal cell skin cancer or carcinoma in situ of the cervix.
- History of thrombotic or hemorrhagic disorder.
- Anticoagulation at treatment/therapeutic doses.
- Uncontrolled hypertension.
- Pre-existing neuropathy > grade 1.
- Treatment with aspirin > 325 mg/day, dipyridamole, ticlopidine, clopidogrel, and/or cilostazol that cannot be discontinued.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Pregnant women are excluded from this study because paclitaxel, carboplatin, and bevacizumab are agents with the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with paclitaxel, carboplatin, and bevacizumab, breastfeeding should be discontinued if the mother is treated with these agents. These potential risks may also apply to other agents used in this study.
About this study
Official title: A Pilot Study of 64CuATSM and Hypoxia in Stage IV Non-small Cell Lung Cancer Patients Treated With Carboplatin, Paclitaxel, and Bevacizumab
The purpose of this study is to determine:
- Whether bevacizumab increases the amount of oxygen in cancer as measured by a special positron emission tomography (PET) scan using 64Cu-ATSM.
- Whether the amount of oxygen in cancer as measured by 64Cu-ATSM PET scan predicts how well the cancer responds to treatment with chemotherapy.
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Being tested
- 64Cu-ATSM PET
- 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.
64Cu-ATSM PETDrug
2 64Cu-ATSM PET scan, one pretreatment and one 19-21 days after the first dose of bevacizumab
| Study group | Role | What they receive |
|---|---|---|
| 64Cu-ATSM PET | Experimental | Not described Receives: Drug: 64Cu-ATSM PET |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether bevacizumab improves tumor hypoxia as measured by 64Cu-ATSM-PET in patients with previously untreated metastatic NSCLC.
Measured: 3 years
Secondary outcomes (1)
To determine whether bevacizumab and chemotherapy improves response rates in tumors defined to be hypoxia by 64-Cu-ATSM-PET in patients with treatment-naïve NSCLC than what would be expected with chemotherapy alone.
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 posted2 Nov 2009 (estimated)
Why it stopped: Withdrawn due to funding issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria Baggstrom, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01006226
- Sponsor's protocol ID
- 09-1640
- Status last verified
- Jul 2013
- First submitted
- 29 Oct 2009
- Last updated
- 23 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of 64CuATSM and Hypoxia in Stage IV Non-small Cell Lung Cancer Patients Treated With Carboplatin, Paclitaxel, and Bevacizumab
- ClinicalTrials.gov ID
- NCT01006226
- Acronym / sponsor ID
- 09-1640
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Withdrawn due to funding issues
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- First posted
- 2 Nov 2009 (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 purpose of this study is to determine:
- Whether bevacizumab increases the amount of oxygen in cancer as measured by a special positron emission tomography (PET) scan using 64Cu-ATSM.
- Whether the amount of oxygen in cancer as measured by 64Cu-ATSM PET scan predicts how well the cancer responds to treatment with chemotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 64Cu-ATSM PET | Experimental | Drug: 64Cu-ATSM PET |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Patients must have histologically or cytologically confirmed non-squamous NSCLC.
- Clinically or pathologically proven Stage IV NSCLC.
- Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >20 mm with conventional techniques or as >10 mm irrespective of scanner type.
- No previous chemotherapy.
- Age >18 years.
Key exclusion criteria (15 listed)
- Patients who have had prior chemotherapy.
- Patients who have had prior radiation therapy for lung cancer.
- Patients may not be receiving any other investigational agents.
- Patients with known central nervous system metastases.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to 64Cu-ATSM or other agents used in the study.
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 |
|---|---|---|
| 64Cu-ATSM PET2 64Cu-ATSM PET scan, one pretreatment and one 19-21 days after the first dose of bevacizumab | Drug | 64Cu-ATSM PET |
Primary outcome
To determine whether bevacizumab improves tumor hypoxia as measured by 64Cu-ATSM-PET in patients with previously untreated metastatic NSCLC.
Time frame: 3 years
1 secondary outcome
To determine whether bevacizumab and chemotherapy improves response rates in tumors defined to be hypoxia by 64-Cu-ATSM-PET in patients with treatment-naïve NSCLC than what would be expected with chemotherapy alone.
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2013.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink 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.
Maria Baggstrom, M.D. principal investigator
Washington University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing 64Cu-ATSM PET in people with Carcinoma, Non-Small-Cell Lung, run by Washington University School of Medicine.
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 21 inclusion and 15 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: withdrawn, as of the sponsor's last update on 23 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 whether bevacizumab improves tumor hypoxia as measured by 64Cu-ATSM-PET in patients with previously untreated metastatic NSCLC. (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 23 Jul 2013.