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A Pilot Study of 64CuATSM and Hypoxia in Stage IV Non-small Cell Lung Cancer Patients Treated With Carboplatin, Paclitaxel, and Bevacizumab

18 Years
Not Enrolling
Carcinoma, Non-Small-Cell Lung

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Trial Information

A Pilot Study of 64CuATSM and Hypoxia in Stage IV Non-small Cell Lung Cancer Patients Treated With Carboplatin, Paclitaxel, and Bevacizumab

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


- 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

- 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

- 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

- 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.

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine whether bevacizumab improves tumor hypoxia as measured by 64Cu-ATSM-PET in patients with previously untreated metastatic NSCLC.

Outcome Time Frame:

3 years

Safety Issue:


Principal Investigator

Maria Baggstrom, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Anoxia



Washington University School of Medicine Saint Louis, Missouri  63110