Clinical trial NCT00411593 (phase 1/phase 2, status: withdrawn)
Conditions: lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: bevacizumab, bortezomib
SMILES: [H][N]1([H])[C@@H]2CCCC[C@H]2[N]([H])([H])[Pt]11OC(=O)C(=O)O1, ClCCN(CCCl)P1(=O)NCCCO1
Reason stopped: 
    lack of patient accrual
  
Eligibility criteria:

        Inclusion Criteria:

          1. Voluntary written informed consent before performance of any study-related procedure
             not part of normal medical care, with the understanding that consent may be withdrawn
             by the subject at any time without prejudice to future medical care.

          2. Female subject is either post-menopausal (Postmenopausal women must be amenorrheic for
             at least 12 months to be considered of non-childbearing potential) or surgically
             sterilized or willing to use an acceptable method of birth control (i.e. a hormonal
             contraceptive, intra-uterine device, diaphragm with spermicide, condom with
             spermicide, or abstinence) for the duration of the study. Male subject agrees to use
             an acceptable method for contraception for the duration of the study.

          3. All patients must have an Eastern Cooperative Oncology Group (ECOG)Performance Status
             of 0 - 2

          4. Patients must have histologically or cytologically proven selected Stage IIIB (T4
             lesion due to malignant pleural or pericardial effusion) or Stage IV advanced
             non-small cell lung cancer or recurrent disease after previous surgery and/or
             radiation.

          5. No history of or active brain metastases

          6. Patients must have measurable disease documented by computed tomography (CT) or
             magnetic resonance imaging (MRI). Measurable disease must be assessed within 28 days
             prior to registration. Pleural effusions, ascites and laboratory parameters are not
             acceptable as the only evidence of disease.

          7. Recurrent or progressive cancer can be within a previously radiated site

          8. Patients must have received one or two prior systemic therapies, one of which
             contained a platinum compound. No prior Bortezomib or antiangiogenic agent is
             permitted. Prior radiation is permitted; however, at least two weeks must have elapsed
             since the completion of prior radiation therapy and patients must have recovered from
             all associated toxicities at the time of registration. At least two weeks must have
             elapsed since surgery (thoracic or other major surgeries) and patients must have
             recovered from all associated toxicities at the time of registration.

          9. Patients must have a serum creatinine </= the institutional upper limit of normal
             (i.e. 1.5 mg/dL) AND a creatinine clearance >/= 40 cc/min determined by either urine
             collection and testing or calculation using the following formula: Calculated
             Creatinine Clearance = (140 - age) * Weight(kg) * (0.85 if female)/ 72 * creatinine
             (mg/dL)

         10. Patients must have an Absolute neutrophil count (ANC)>/= 2,000/µl and platelet count
             >/= 100,000/µl obtained within 28 days prior to registration. Hemoglobin: >9.0 *
             10^9/L

         11. Patients must have adequate hepatic function documented by a serum bilirubin </=
             institutional upper limit of normal (1.0) and liver enzymes (serum glutamic
             oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT)) </= 3.0
             * the institutional upper limit of normal obtained within 28 days prior to
             registration

         12. Peripheral neuropathy, if present, must be < Grade 2 (NCI Common Terminology Criteria
             for Adverse Events Version 3.0).

         13. Patients known to be HIV-positive and taking HAART therapy are not eligible due to
             possible pharmacokinetic interactions

         14. Patients must not be planning to receive any other concomitant anticancer treatment
             including chemotherapy, radiation therapy, biologic agents or any other
             investigational drugs

         15. Patient must be >/= 18 years of age.

         16. Patients must be informed of the investigation nature of this study and must sign and
             give written informed consent in accordance with institutional and federal guidelines.

        Exclusion Criteria:

          1. Patients meeting any of the following exclusion criteria are not to be enrolled in the
             study. Participation in an experimental drug study within 4 weeks of the first
             treatment on this trial: Blood pressure > 140/90 mm Hg, History of stroke within 6
             months, Clinically significant peripheral vascular disease, Evidence of bleeding
             diathesis or coagulopathy, Presence of central nervous system or brain metastases

          2. Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study.

          3. Minor surgical procedures such as fine needle aspirations or core biopsies within 7
             days prior to Day 0

          4. Urine protein: creatinine ratio >/= 1.0 at screening

          5. Serious non-healing wound, ulcer, or bone fracture

          6. Myocardial infarction within 6 months prior to enrollment or has New York Heart
             Association (NYHA) Class II or heart failure, unstable angina, severe uncontrolled
             ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active
             conduction system abnormalities. Prior to study entry, and ECG abnormality at
             Screening has to be documented by the investigator as not medically relevant

          7. Patients with squamous histology

          8. Patients with hematemesis or more than ½ teaspoon of hemoptysis within 6 months of
             study entry.

          9. Patients requiring full dose oral or parenteral anticoagulation.

         10. Abdominal fistula, GI perforation, or abdominal abscess within the last 6 months

         11. Patient has hypersensitivity to boron or mannitol

         12. Female subject is pregnant or breast-feeding. Confirmation that the subject is not
             pregnant must be established by a negative serum beta-human chorionic gonadotropin
             (beta-hCG) pregnancy test result obtained during screening. Pregnancy testing is not
             required for post-menopausal or surgically sterilized women. Patient has received
             other investigational drugs within 28 days before enrollment

         13. Serious medical or psychiatric illness likely to interfere with participation in this
             clinical study

         14. No other prior or concurrent malignancy is allowed except for: non-melanoma skin
             cancers, in situ cervical cancer, and any cancer from which the patient has been
             disease-free for 3 years or more.

         15. Pregnant or nursing women may not participate in this trial because of the increased
             risk of fetal harm including fetal death from the chemotherapeutic agents. Women/men
             of reproductive potential may not participate unless they have agreed to use an
             effective contraceptive method.

         16. Patients requiring treatment with Nonsteroidal anti-inflammatory drugs (NSAIDS),
             antiplatelet agents, or aspirin > 325 mg/day