Carboplatin, Pemetrexed Disodium, and Bevacizumab for Patients With Stage III or IV Non-Small Cell Lung Cancer Who Are Light/Never Smokers

NCT01344824 | Completed Phase 2 Results DMC

• 2 other identifiers: LCCC 0825P30CA016086
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 4

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Pemetrexed disodium may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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. Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor. Giving carboplatin and pemetrexed disodium together with bevacizumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving carboplatin and pemetrexed disodium together with bevacizumab works in treating patients with stage III or stage IV non-small cell lung cancer who are light or never smokers.

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer; adenocarcinoma of the lung; bronchoalveolar cell lung cancer; large cell lung cancer

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Documented radiographic response per Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by imaging: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. criteria each year, until subject death

  1400 days

Secondary Outcomes (2)

• Overall Survival

  1400 days

• Subjects Experiencing Toxicity

  90 days

Study Arms (1)

Single Arm Trial

OTHER

Bevacizumab, Carboplatin, and Pemetrexed disodium, with option for second line erlotinib hydrochloride

Biological: bevacizumab; Drug: carboplatin; Drug: erlotinib hydrochloride; Drug: pemetrexed disodium

Interventions

bevacizumab BIOLOGICAL

15 mg/kg once per 21 day cycle (up to 4 cycles).

Also known as: Avastin

Single Arm Trial

carboplatin DRUG

Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)

Also known as: Paraplatin

Single Arm Trial

erlotinib hydrochloride DRUG

150mg, daily for 21 day cycle (up to 4 cycles)

Also known as: Tarceva

Single Arm Trial

pemetrexed disodium DRUG

500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)

Also known as: ALIMTA

Single Arm Trial

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed primary lung carcinoma * Non-squamous histology * Advanced disease defined as stage IIIB disease with cytologically documented malignant pleural or pericardial effusion or stage IV disease * Available pathology block or unstained slides from initial or subsequent diagnosis * Must have undergone ≥ 1 core biopsy * No patients whose diagnosis was made through a fine-needle aspirate * No uncontrolled pleural effusions, ascites, or third-space fluid collections * Meets 1 of the following criteria: * Non-smoker, defined as patients who smoked ≤ 100 cigarettes in their lifetime * Former light smoker, defined as patients who smoked between \> 100 cigarettes AND ≤ 10 pack-years AND quit ≥ 1 year ago * No known central nervous system disease, except for treated brain metastases meeting the following criteria: * No evidence of progression or hemorrhage after treatment * No ongoing requirement for dexamethasone as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period * Stable doses of anticonvulsants are allowed * Treatment for brain metastases may include whole-brain radiotherapy, radiosurgery (gamma knife, LINAC, or equivalent), or a combination as deemed appropriate by the treating physician * No patients with central nervous system (CNS) metastases treated by neurosurgical resection * No brain biopsy within the past 3 months PATIENT CHARACTERISTICS: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count (ANC) ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Hemoglobin ≥ 9.0 g/dL * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Aspartate aminotransferase (AST/ALT) ≤ 2.5 times ULN * Calculated creatinine clearance \> 45 mL/min OR creatinine ≤ 1.5 times ULN * Prothrombin time ≤ 1.5 times ULN * Partial thromboplastin time ≤ ULN * Urine protein:creatinine ratio ≤ 1.0 * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Patients with a history of hypertension are eligible provided it is well controlled (BP \< 150/100 mm Hg) on a stable regimen of antihypertensive therapy * No history of hypertensive crisis or hypertensive encephalopathy * Able and compliant with folic acid and B12 supplementation * Able to swallow tablets intact or dissolved in water * No dysphagia or active gastrointestinal (GI) disease or disorder that alters GI motility or absorption * No lack of integrity of the GI tract (e.g., a significant surgical resection of the stomach or small bowel) * No abdominal fistula, GI perforation, or intraabdominal abscess within the past 6 months * None of the following: * Ongoing or active infection * Symptomatic congestive heart failure (NYHA class II-IV) * Cardiac arrhythmia * Psychiatric illness, social situations, or any other medical condition that would limit compliance with study requirements * No myocardial infarction or other evidence of arterial thrombotic disease (angina) within the past 6 months * No history of cerebral vascular accident or transient ischemic attack within the past 6 months * No significant vascular disease (e.g., aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within the past 6 months * No history of bleeding diathesis or coagulopathy * No ongoing hemoptysis, defined as ≥ ½ teaspoon of bright red blood * Patients with procedure-related hemoptysis that has resolved post-procedure are eligible * No serious nonhealing wound, ulcer, bone fracture, or significant traumatic injury within the past 28 days * No known hypersensitivity to Chinese hamster ovary cell products or other recombinant human antibodies PRIOR CONCURRENT THERAPY: * No prior chemotherapy * Patient must be chemotherapy naive * Prior neoadjuvant or adjuvant chemotherapy allowed provided it was completed ≥ 6 months ago * No prior anti-vascular endothelial growth factor therapy * At least 3 weeks since prior major surgery * At least 1 week since prior radiotherapy * More than 28 days since prior and no concurrent treatment with an investigational agent * More than 7 days since prior core biopsy * Concurrent daily treatment with aspirin or NSAIDs are eligible provided patients are able to interrupt NSAIDs 2 days before (5 days for long-acting NSAIDs), the day of, and for 2 days following the administration of pemetrexed disodium * No concurrent treatment with dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix), and/or cilostazol (Pletal)

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Mission Hospital

Asheville, North Carolina, 28801, United States

Location

Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Chapel Hill, North Carolina, 27599-7295, United States

Location

CCHC New Bern Cancer Care

New Bern, North Carolina, 28562, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15232, United States

Location

Related Publications (1)

• Weiss JM, Villaruz LC, O'Brien J, Ivanova A, Lee C, Olson JG, Pollack G, Gorman R, Socinski MA, Stinchombe TE. Results of a Phase II Trial of Carboplatin, Pemetrexed, and Bevacizumab for the Treatment of Never or Former/Light Smoking Patients With Stage IV Non-Small Cell Lung Cancer. Clin Lung Cancer. 2016 Mar;17(2):128-32. doi: 10.1016/j.cllc.2015.12.006. Epub 2015 Dec 17.

  PMID: 26774201 RESULT

Related Links

• UNC Lineberger Comprehensive Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar

Interventions

Bevacizumab; Carboplatin; Erlotinib Hydrochloride; Pemetrexed

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

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; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Guanine; Hypoxanthines; Purinones; Purines; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Dicarboxylic

Results Point of Contact

• Title: Robin V. Johnson
• Organization: UNC Lineberger Comprehensive Cancer Center

Robin_V_Johnson@med.unc.edu

919-966-1125

Study Officials

• Thomas E. Stinchcombe, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2011
• First Posted: April 29, 2011
• Study Start: March 1, 2010
• Primary Completion: May 24, 2016
• Study Completion: July 20, 2016
• Last Updated: October 30, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)