- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01006226
64CuATSM and Hypoxia in Stage IV Non-small Cell Lung Cancer With Carboplatin, Paclitaxel, and Bevacizumab
July 22, 2013 updated by: Washington University School of Medicine
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 64Cu-ATSM PET
|
2 64Cu-ATSM PET scan, one pretreatment and one 19-21 days after the first dose of bevacizumab
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
To determine whether bevacizumab improves tumor hypoxia as measured by 64Cu-ATSM-PET in patients with previously untreated metastatic NSCLC.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted
October 29, 2009
First Submitted That Met QC Criteria
October 30, 2009
First Posted (Estimate)
November 1, 2009
Study Record Updates
Last Update Posted (Estimate)
July 23, 2013
Last Update Submitted That Met QC Criteria
July 22, 2013
Last Verified
July 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 09-1640
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Carcinoma, Non-Small-Cell Lung
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Bristol-Myers SquibbCompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage I Non-Small Cell Lung Cancer | Stage II Non-Small Cell Lung Cancer | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung Carcinoma | Non-Squamous Non-Small...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Recurrent Non-Small Cell Lung Carcinoma | Stage IV Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingLung Non-Squamous Non-Small Cell Carcinoma | Stage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7United States, Puerto Rico
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Active, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Recurrent Lung Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IA...United States
-
National Cancer Institute (NCI)TerminatedStage IIIA Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
M.D. Anderson Cancer CenterActive, not recruitingStage IB Lung Non-Small Cell Carcinoma AJCC v7 | Stage II Lung Non-Small Cell Cancer AJCC v7 | Stage IIA Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIB Lung Non-Small Cell Carcinoma AJCC v7 | Stage IIIA Lung Non-Small Cell Cancer AJCC v7 | Stage I Lung Non-Small Cell Cancer AJCC v7 | Stage...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); Society of Thoracic RadiologyActive, not recruitingStage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IIIA Lung Non-Small Cell Cancer AJCC v7 | Advanced Lung Non-Squamous Non-Small Cell Carcinoma | Metastatic Lung Non-Squamous Non-Small Cell Carcinoma | Stage IIIB Lung Non-Small Cell Cancer AJCC v7 | Stage IV Lung Non-Small Cell Cancer AJCC v7 | Stage III Lung Non-Small Cell Cancer AJCC...United States
-
National Cancer Institute (NCI)CompletedStage IIIA Non-Small Cell Lung Cancer | Stage IIIB Non-Small Cell Lung Cancer | Stage IIA Non-Small Cell Lung Carcinoma | Stage IIB Non-Small Cell Lung Carcinoma | Stage IA Non-Small Cell Lung Carcinoma | Stage IB Non-Small Cell Lung CarcinomaUnited States
Clinical Trials on 64Cu-ATSM PET
-
Institut Cancerologie de l'OuestFondation ARCActive, not recruiting
-
Peter CaravanNational Heart, Lung, and Blood Institute (NHLBI)RecruitingDeep Vein Thrombosis | Venous Thromboembolism | Pulmonary EmbolismUnited States
-
Rigshospitalet, DenmarkRecruitingCardiac SarcoidosisDenmark
-
Washington University School of MedicineNational Cancer Institute (NCI)RecruitingPancreatic Ductal AdenocarcinomaUnited States
-
Massachusetts General HospitalNational Heart, Lung, and Blood Institute (NHLBI)RecruitingCOVID-19 | Cancer | Thrombosis | Atrial FibrillationUnited States
-
Rahul AggarwalNational Cancer Institute (NCI); U.S. Army Medical Research Acquisition ActivityRecruitingProstate Cancer | Advanced Solid Tumor | Renal Cancer | Urethral Cancer | Solid Tumor, Adult | Metastatic Castration-resistant Prostate CancerUnited States
-
American College of RadiologyNational Cancer Institute (NCI); American College of Radiology Imaging NetworkTerminated
-
University of California, San FranciscoAgency for Healthcare Research and Quality (AHRQ); San Francisco Health Plan...Completed
-
Memorial Sloan Kettering Cancer CenterRecruitingPancreatic Cancer | Pancreatic Ductal Adenocarcinoma | Metastatic Pancreatic Cancer | Metastatic Pancreatic Ductal Adenocarcinoma | Primary Pancreatic Ductal AdenocarcinomaUnited States
-
Collaborative Medicinal Development Pty LimitedUnknown