Randomized Phase II Trial Comparing Bevacizumab Plus Carboplatin and Paclitaxel With Carboplatin and Paclitaxel Alone in Previously Untreated Locally Advanced or Metastatic Non-Small-Cell Lung Cancer.

Purpose: To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer.

Patients And Methods: In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m) every 3 weeks or carboplatin and paclitaxel alone (n = 32).

Phase II trial of sorafenib and erlotinib in advanced pancreatic cancer.

This trial was designed to assess efficacy and safety of erlotinib with sorafenib in the treatment of patients with advanced pancreatic adenocarcinoma. An exploratory correlative study analyzing pretreatment serum samples using a multivariate protein mass spectrometry-based test (VeriStrat®), previously shown to correlate with outcomes in lung cancer patients treated with erlotinib, was performed. Patients received sorafenib 400 mg daily along with erlotinib 150 mg daily with a primary endpoint of 8-week progression free survival (PFS) rate.

A phase II study of carboplatin and irinotecan in extensive stage small-cell lung cancer.

Objectives: Our study set out to determine the antitumor efficacy of carboplatin and irinotecan as assessed by response rate in persons with chemotherapy-naive extensive-disease, small-cell lung cancer (ED-SCLC). Secondary objectives included progression-free survival (PFS), overall survival, and toxicity findings.

Methods: Patients with previously untreated ED-SCLC, Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-2, life expectancy ≥ 3 months, and adequate organ function were eligible.

Estimating sustaining base-hospital personnel requirements during extended operations.

This case study provides a unique method for estimating sustaining base military hospital personnel requirements during combat and stability operations while underscoring the need for such analysis before the commencement of combat operations. The requirement estimates are based on a major combat operation (MCO) scenario, which was extended to simulate stability operations. The scenario selected derived from Department of Defense strategic planning guidance as modeled by the Total Army Analysis (TAA).

Nonlinear wavelet image processing: variational problems, compression, and noise removal through wavelet shrinkage.

This paper examines the relationship between wavelet-based image processing algorithms and variational problems. Algorithms are derived as exact or approximate minimizers of variational problems; in particular, we show that wavelet shrinkage can be considered the exact minimizer of the following problem. Given an image F defined on a square I, minimize over all g in the Besov space B(1)(1)(L (1)(I)) the functional |F-g|(L2)(I)(2)+lambda|g|(B(1)(1 )(L(1(I)))).

Implementation of low-fat, low-sugar, and portion-controlled nutrition guidelines in competitive food venues of Maine public high schools.

Background: The prevalence of childhood "overweight" and "at risk for overweight" has become a major public health concern. School food environments can affect key nutritional risk factors, especially in high schools where foods of poor nutrient value are pervasive in à la carte and vending programs. This study examines à la carte and vending programs in Maine public high schools at baseline and following implementation of low-fat (defined as items View Article and Find Full Text PDF

The challenge of mapping between two medical coding systems.

Objective: Deployable medical systems patient conditions (PCs) designate groups of patients with similar medical conditions and, therefore, similar treatment requirements. PCs are used by the U.S.

The vending and à la carte policy intervention in Maine public high schools.

Background: A healthy school nutrition environment may be important for decreasing childhood overweight. This article describes a project to make healthier snacks and beverages available in vending machines and à la carte programs in Maine public high schools.

Context: Seven public high schools in Maine volunteered to participate in this project.

Diet-induced thermogenesis: variations among three isocaloric meal-replacement shakes.

Objective: We determined whether significant differences exist in diet-induced thermogenesis among three low-calorie (1042 kJ, or 250 kcal), liquid meal-replacement shakes of different macronutrient compositions: 1) 100% protein; 2) 62% protein, 28% carbohydrate, and 10% fat (high protein/low carbohydrate); and 3) 17% protein, 75% carbohydrate, and 8% fat (low protein/high carbohydrate).

Methods: Eight subjects (three men and five women) completed a randomized, double-blind, crossover investigation involving three separate resting-and-reclining energy expenditure measurements taken before and after consumption of one of the shakes. Resting-and-reclining metabolic gas-exchange measurements were taken for 30 min; subjects then drank a 20-oz shake, after which 3 h of additional resting-and-reclining gas-exchange measurements were taken.

Status of trauma care in U.S. Army hospitals.

Objective: This study documents the recent trends and current state of inpatient trauma care in U.S. Army hospitals.

Wavelet compression of three-dimensional time-lapse biological image data.

The use of multifocal-plane, time-lapse recordings of living specimens has allowed investigators to visualize dynamic events both within ensembles of cells and individual cells. Recordings of such four-dimensional (4D) data from digital optical sectioning microscopy produce very large data sets. We describe a wavelet-based data compression algorithm that capitalizes on the inherent redunancies within multidimensional data to achieve higher compression levels than can be obtained from single images.

Phase II study of the farnesyl transferase inhibitor R115777 in patients with sensitive relapse small-cell lung cancer.

Background: R115777 (tipifarnib, Zarnestra) is a farnesyl transferase inhibitor that blocks the farnesylation of proteins involved in signal transduction pathways critical for cell proliferation and survival. This multicenter phase II study was conducted to determine the efficacy, tolerability and pharmacokinetics of R115777 in patients with relapsed small-cell lung cancer (SCLC).

Patients And Methods: Patients who had a partial or complete response to their initial chemotherapy regimen, followed by at least 3 months off treatment before relapse (sensitive relapse) were eligible.

Randomized phase II trial comparing bevacizumab plus carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously untreated locally advanced or metastatic non-small-cell lung cancer.

Purpose: To investigate the efficacy and safety of bevacizumab plus carboplatin and paclitaxel in patients with advanced or recurrent non-small-cell lung cancer.

Patients And Methods: In a phase II trial, 99 patients were randomly assigned to bevacizumab 7.5 (n = 32) or 15 mg/kg (n = 35) plus carboplatin (area under the curve = 6) and paclitaxel (200 mg/m(2)) every 3 weeks or carboplatin and paclitaxel alone (n = 32).

Docetaxel and cisplatin in patients with advanced non small-cell lung cancer (NSCLC): a multicenter phase II trial.

We examined the safety and efficacy of the docetaxel/cisplatin combination in patients with advanced, previously untreated NSCLC and evaluated changes in quality of life over time. Docetaxel was administered before cisplatin (both 75 mg/m2, 1-hour infusions) every 3 weeks to 47 patients with stage IIIB or stage IV NSCLC. Patients also received premedication of oral dexamethasone.

A phase I trial of outpatient weekly docetaxel and concurrent radiation therapy for stage III unresectable non small-cell lung cancer: a Vanderbilt Cancer Center Affiliate Network (VCCAN) Trial.

Docetaxel has demonstrated activity as a radiosensitizer in numerous preclinical studies, probably due to its role as a cell cycle synchronizer for the G2/M radiosensitive phase of the cell cycle. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of docetaxel with concurrent thoracic radiation therapy (TRT) to patients with unresectable stage III non small-cell lung cancer (NSCLC). Fifteen patients were entered into this study.

Phase II trial of gemcitabine in refractory or relapsed small-cell lung cancer: Eastern Cooperative Oncology Group Trial 1597.

Purpose: Gemcitabine has shown a broad range of activity in solid tumors, including previously untreated small-cell lung cancer (SCLC). The objective of this phase II trial was to investigate the activity of gemcitabine in patients with relapsed SCLC.

Patients And Methods: SCLC patients with measurable disease who had experienced treatment failure with one prior chemotherapy regimen were considered eligible.

Phase I trial of outpatient weekly docetaxel, carboplatin and concurrent thoracic radiation therapy for stage III unresectable non-small-cell lung cancer: a Vanderbilt cancer center affiliate network (VCCAN) trial.

Purpose: Docetaxel, an active agent for non-small cell lung cancer (NSCLC), has demonstrated activity as a radiosensitizer in numerous pre-clinical studies. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly Docetaxel, Carboplatin with concurrent thoracic radiation therapy (TRT) in patients with unresectable stage III NSCLC.

Patients And Methods: In this phase I clinical trial, Docetaxel was administered weekly as a 1-h intravenous infusion for 6 weeks with a starting dose of 20 mg/m(2).

Induction chemotherapy increases perioperative complications in patients undergoing resection for non-small cell lung cancer.

Background: Neoadjuvant chemotherapy before resection is the standard of care for stage IIIA non-small cell lung cancer in many institutions. Further, neoadjuvant therapy is being studied in earlier stage lung cancer and may be applied more broadly in the future. There is little information about the effect of preoperative chemotherapy on the perioperative complications and mortality after lung resection.

Topotecan versus observation after cisplatin plus etoposide in extensive-stage small-cell lung cancer: E7593--a phase III trial of the Eastern Cooperative Oncology Group.

Purpose: To determine the efficacy of topotecan in combination with standard chemotherapy in previously untreated patients with extensive-stage small-cell lung cancer (SCLC), the Eastern Cooperative Oncology Group (ECOG) conducted a phase III trial.

Patients And Methods: Eligible patients had measurable or assessable disease and an ECOG performance status of 0 to 2; stable brain metastases were allowed. All patients received four cycles of cisplatin and etoposide every 3 weeks (step 1; PE).

A phase II trial of 6-hydroxymethylacylfulvene (MGI-114, irofulven) in patients with advanced non-small cell cancer previously treated with chemotherapy.

Purpose: To test the efficacy and safety of the novel antitumor agent MGI-114 (NSC 683863) in patients with advanced non-small cell lung cancer (NSCLC) previously treated with chemotherapy.

Methods: A two-stage accrual design was used to ensure detection of a true response rate of at least 20% with a type I error of .04.

Weekly irinotecan and cisplatin in advanced non-small cell lung cancer: a multicenter phase II study.

The combination of weekly irinotecan (CPT-11) and monthly cisplatin has shown promising activity in advanced non-small cell lung cancer (NSCLC) in previous Phase I and II studies. However, same-day administration of these agents may better exploit their therapeutic synergy and minimize toxicities. This multicenter Phase II study was undertaken to evaluate the efficacy and safety of a combination of weekly CPT-11 and weekly cisplatin in patients with advanced NSCLC.

Weekly irinotecan and concurrent radiation therapy for stage III unresectable NSCLC.

In preclinical studies, the topoisomerase I inhibitor irinotecan (Camptosar, CPT-11) has demonstrated activity as a radiosensitizer, probably due to its ability to inhibit potentially lethal radiation damage repair. We conducted a phase I trial to determine the maximum-tolerated dose (MTD) and dose-limiting toxicities (DLT) of weekly irinotecan with concurrent thoracic radiation therapy for patients with unresectable stage III non-small-cell lung cancer. For this study, 13 patients received three dose escalations (from 30 to 40 to 50 mg/m2/wk).

A phase II study of paclitaxel, carboplatin, and hyperfractionated radiation therapy for locally advanced inoperable non-small-cell lung cancer (a Vanderbilt Cancer Center Affiliate Network Study).

Purpose: We conducted a prospective phase II study to determine the response rate, toxicity, and survival rate of concurrent weekly paclitaxel, carboplatin, and hyperfractionated radiation therapy (paclitaxel/carboplatin/HFX RT) followed by 2 cycles of paclitaxel and carboplatin for locally advanced unresectable non-small cell lung cancer (NSCLC). The weekly paclitaxel and carboplatin regimen was designed to optimize the radiosensitizing properties of paclitaxel during the concurrent phase of treatment.

Methods And Materials: Forty-three patients with unresectable stage IIIA and IIIB NSCLC from the Vanderbilt Cancer Center and Affiliate Network (VCCAN) institutions were entered onto the study from June 1996 until May 1997.

Randomized phase III trial of docetaxel versus vinorelbine or ifosfamide in patients with advanced non-small-cell lung cancer previously treated with platinum-containing chemotherapy regimens. The TAX 320 Non-Small Cell Lung Cancer Study Group.

Purpose: To confirm the promising phase II results of docetaxel monotherapy, this phase III trial was conducted of chemotherapy for patients with advanced non-small-cell lung cancer (NSCLC) who had previously failed platinum-containing chemotherapy.

Patients And Methods: A total of 373 patients were randomized to receive either docetaxel 100 mg/m(2) (D100) or 75 mg/m(2) (D75) versus a control regimen of vinorelbine or ifosfamide (V/I). The three treatment groups were well-balanced for key patient characteristics.

Multi-institutional phase I/II trial of paclitaxel, cisplatin, and etoposide with concurrent radiation for limited-stage small-cell lung carcinoma.

Purpose: To determine the feasibility of adding paclitaxel to standard cisplatin/etoposide (EP) and thoracic radiotherapy.

Patients And Methods: Thirty-one patients were enrolled onto this study. During the phase I section of this study, the dose of paclitaxel was escalated in groups of three or more patients.