A phase II, randomized, double blind trial of calcium aluminosilicate clay versus placebo for the prevention of diarrhea in patients with metastatic colorectal cancer treated with irinotecan.

Purpose: Calcium aluminosilicate clay (CASAD) is a naturally occurring clay that serves as a cation exchange absorbent. We hypothesized that oral administration of CASAD would reduce the rate of grade 3/4 diarrhea associated with irinotecan use for metastatic colorectal cancer (CRC) by adsorbing the SN-38 metabolite.

Methods: Patients receiving irinotecan-based chemotherapy were randomized equally between CASAD and placebo arms in this multicenter trial in order to assess differences in the proportions of patients with grade 3/4 diarrhea within 6 weeks.

Phase II trial of infusional fluorouracil, irinotecan, and bevacizumab for metastatic colorectal cancer: efficacy and circulating angiogenic biomarkers associated with therapeutic resistance.

Purpose: We investigated the efficacy of fluorouracil (FU), leucovorin, irinotecan, and bevacizumab (FOLFIRI + B) in a phase II trial in patients previously untreated for metastatic colorectal cancer (mCRC), and changes during treatment in plasma cytokines and angiogenic factors (CAFs) as potential markers of treatment response and therapeutic resistance.

Patients And Methods: We conducted a phase II, two-institution trial of FOLFIRI + B. Each 14-day cycle consisted of bevacizumab (5 mg/kg), irinotecan (180 mg/m(2)), bolus FU (400 mg/m(2)), and leucovorin (400 mg/m(2)) followed by a 46-hour infusion of FU (2,400 mg/m(2)).

Phase II trial of the combination of bevacizumab and erlotinib in patients who have advanced hepatocellular carcinoma.

Purpose: The study objective was to determine the proportion of patients with hepatocellular carcinoma (HCC) treated with the combination of bevacizumab (B) and erlotinib (E) who were alive and progression free at 16 weeks (16-week progression-free survival [PFS16]) of continuous therapy. Secondary objectives included response rate, median PFS, survival, and toxicity.

Patients And Methods: Patients who had advanced HCC that was not amenable to surgical or regional therapies, up to one prior systemic treatment; Childs-Pugh score A or B liver function; Eastern Cooperative Oncology Group performance status 0, 1, or 2 received B 10 mg/kg every 14 days and E 150 mg orally daily, continuously, for 28-day cycles.

The association of family history of liver cancer with hepatocellular carcinoma: a case-control study in the United States.

Background/aims: The study aimed at addressing the connection between positive family history of liver cancer and hepatocellular carcinoma (HCC) development in the USA.

Methods: At The University of Texas M.D.

Pathologic response to preoperative chemotherapy: a new outcome end point after resection of hepatic colorectal metastases.

Purpose: The primary goal of this study was to evaluate whether pathologic response to chemotherapy predicts patient survival after preoperative chemotherapy and resection of colorectal liver metastases (CLM). The secondary goal of the study was to identify the clinical predictors of pathologic response.

Patients And Methods: A retrospective review was performed of 305 patients who underwent preoperative irinotecan- or oxaliplatin-based chemotherapy, followed by resection of CLM.

Effect of different types of smoking and synergism with hepatitis C virus on risk of hepatocellular carcinoma in American men and women: case-control study.

The International Agency for Research on Cancer has declared smoking to be a risk factor for hepatocellular carcinoma (HCC). However, passive exposure to cigarette smoke and use of noncigarette tobacco products on the risk of HCC has not been examined. Therefore, we evaluated the independent effects of different types of smoking exposure along with multiple risk factors for HCC and determined whether the magnitude of smoking was modified by other risk factors in men and women.

Systematic survey of therapeutic trials for metastatic colorectal cancer: room for improvement in the critical pathway.

Purpose: The current strategy of drug development has been criticized as being highly inefficient. In 2004, the US Food and Drug Administration (FDA) released recommendations to improve this process, including a push for increased use of enrichment trials. It is unclear to what extent aspects of this "Critical Path Initiative" have been adopted in trial designs in metastatic colorectal cancer.

Second-line chemotherapy use in metastatic colon cancer varies by disease responsiveness.

Background: Improved survival of patients with metastatic colorectal cancer (CRC) has been shown to correlate with increased utilization of the 3 active cytotoxic chemotherapeutic agents: 5-fluorouracil (5-FU), irinotecan, and oxaliplatin, usually administered in 2 lines of therapy. However, it is unclear which patient, disease, and treatment characteristics are associated with the utilization of a second-line regimen.

Patients And Methods: We performed a retrospective chart review.

Phase 2 study of erlotinib in patients with unresectable hepatocellular carcinoma.

Background: Growth factor overexpression, including epidermal growth factor receptor (EGFR) expression, is common in hepatocellular cancers. Erlotinib is a receptor tyrosine kinase inhibitor with specificity for EGFR. The primary objective of this study was to determine the proportion of hepatocellular carcinoma (HCC) patients treated with erlotinib who were alive and progression-free (PFS) at 16 weeks of continuous treatment.

A review of small-molecule epidermal growth factor receptor-specific tyrosine kinase inhibitors in development for non-small cell lung cancer.

Overexpression of the epidermal growth factor receptor is commonly seen in a variety of epithelial tumors including lung cancer, and it is particularly common in the non-small cell histologic variant. Despite intense research efforts, therapeutic advances to date have failed to result in a significant survival benefit for patients with advanced disease. The lack of overall survival benefit and high toxicity associated with cytotoxic chemotherapy indicates the need for novel therapies that have a favorable effect on survival with minimal toxicity.

Chemoprevention of head and neck cancer.

Squamous cell carcinoma of the head and neck is the most common epithelial neoplasm of the upper aerodigestive tract and represents a major health concern in the United States and worldwide. Invasive squamous cell carcinoma is the end result of a multiyear, multistep process of accumulation of genetic and phenotypic damage. Chemoprevention is defined as the use of pharmacologic or natural agents that inhibit the development of invasive cancer whether by blocking the DNA damage that initiates carcinogenesis or by arresting or reversing the progression of premalignant cells in which such damage has already occurred.