Enzastaurin, Carboplatin, and Gemcitabine With or Without Bevacizumab in Treating Patients With Recurrent, Stage IIIB, or Stage IV Non-Small Cell Lung Cancer

NCT00469976 | Withdrawn Phase 2

• 2 other identifiers: CDR0000542546ECOG-E3506
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Enzastaurin may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving enzastaurin together with carboplatin and gemcitabine, with or without bevacizumab, may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving enzastaurin together with carboplatin and gemcitabine, with or without bevacizumab, works in treating patients with recurrent, stage IIIB, or stage IV non-small cell lung cancer.

Conditions

Lung Cancer

Keywords

stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; recurrent non-small cell lung cancer

Outcome Measures

Primary Outcomes (2)

• Progression-free survival at 6 months (group 1)

• Progression-free survival at 4.5 months (group 2)

Interventions

bevacizumab DRUG

carboplatin DRUG

enzastaurin hydrochloride DRUG

gemcitabine hydrochloride DRUG

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) * Stage IIIB (with confirmed malignant pleural effusion), stage IV, or recurrent disease * Mixed tumors categorized by the predominant cell type are allowed provided no small cell elements exist * Cytologic or histologic elements can be established on metastatic tumor aspirates or biopsy * Measurable disease as defined by RECIST criteria * No squamous cell carcinoma (group 1) * No history of brain metastases (group 1) * History of treated brain metastases allowed provided patient is not taking steroids and anti-seizure mediation (group 2) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * ANC ≥ 1,500/mm³ * Platelet count ≥ 100,000/mm³ * Bilirubin ≤ 1.5 mg/dL * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase ≤ 3 times ULN (≤ 5 times ULN with liver metastases) * AST and ALT ≤ 3 times ULN (≤ 5 times ULN with liver metastases) * INR \< 1.5 or PTT normal (group 1) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during (groups 1 and 2) and for 6 months after completion of study treatment (group 1) * No preexisting peripheral neuropathy ≥ grade 2 * Must be able to swallow tablets * No cardiovascular condition, including any of the following: * Myocardial infarction within the past 6 months * Cerebrovascular ischemia or stroke within the past 6 months * NYHA congestive heart failure \> class II * Unstable angina pectoris * Serious cardiac arrhythmia requiring medication * Significant vascular disease * Symptomatic peripheral vascular disease * No concurrent medical condition, psychiatric illness, or limitations that would limit study compliance * No ongoing active infection or ongoing fever within the past 6 months * No history of uncontrolled hypertension, defined as blood pressure ≥ 150/90 mm Hg despite being on a stable regimen of anti-hypertensive therapy * No serious nonhealing wound, ulcer, or bone fracture within the past 4 weeks * No ongoing or active infection * No history of thrombotic or hemorrhagic disorders, bleeding diathesis, or coagulopathy (group 1) * No bleeding \> grade 2 or any bleeding requiring intervention within the past 4 weeks (group 1) * No history of gross hemoptysis (defined as \> ½ teaspoon of bright red blood) (group 1) * Urine protein:creatinine (UPC) ratio \< 1.0 by spot urinalysis * For UPC ratio \> 0.5, a 24-hour urine protein must be obtained and the urine protein level must be \< 1,000 mg (group 1) * None of the following conditions (group 1): * Grade II or greater peripheral vascular disease * Abdominal fistula * Gastrointestinal perforation * Intra-abdominal abscess * No known hypersensitivity to any component of bevacizumab (group 1) * No history of hypertensive crisis or hypertensive encephalopathy (group 1) PRIOR CONCURRENT THERAPY: * More than 4 weeks since prior major surgical procedure * More than 7 days since prior minor surgical procedure * No prior chemotherapy for advanced NSCLC * Postoperative adjuvant chemotherapy for previously resected NSCLC allowed if last dose was given \> 1 year ago * More than 3 weeks since prior radiation therapy and recovered * More than 3 weeks since prior immunotherapy and/or hormonal therapy (not including hormone replacement therapy or contraceptives) and recovered * More than 14 days since prior enzyme inducing anti-epileptic drugs (EIAEDs) * More than 10 days since prior and no concurrent daily treatment with acetylsalicylic acid (\> 325 mg/day) or NSAIDs known to inhibit platelet function for chronic conditions (group 1) * No concurrent major surgical procedure (group 1) * No concurrent carbamazepine, phenobarbital, or phenytoin * No concurrent therapeutic anticoagulation (group 1) * Prophylactic anticoagulation of venous access devices is allowed * No concurrent treatment with dipyridamole, ticlopidine, clopidogrel, or cilostazol (group 1) * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eastern Cooperative Oncology Group: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Bevacizumab; Carboplatin; Gemcitabine

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Coordination Complexes; Organic Chemicals; Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Athanassios Argiris, MD

  University of Pittsburgh

  STUDY CHAIR

• Chandra P. Belani, MD

  Milton S. Hershey Medical Center

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 3, 2007
• First Posted: May 7, 2007
• Study Start: June 1, 2007
• Last Updated: October 8, 2015

Record last verified: 2015-10