December 2011: Trials in Progress

OBTN
Published: Monday, Jan 16, 2012
The Trials in Progress section is intended to stimulate discussion about ongoing clinical trials and to promote collaboration across the oncology community. Each month, OBTN will present summaries of ongoing research in a broad range of cancer types.

Breast Cancer

Evaluating trastuzumab/capecitabine and pertuzumab in patients whose cancer has progressed

Researchers are recruiting for the multicenter, randomized PHEREXA study. The phase II, 2-arm study will examine the safety and efficacy of giving pertuzumab and trastuzumab with capecitabine in women with HER2- positive metastatic breast cancer whose disease has progressed during or following trastuzumab therapy. As of January 2011, researchers have recruited 58 patients for this open-label trial, but they hope to recruit 450 patients from 19 countries. Patients in both arms will receive trastuzumab and capecitabine, while 1 arm will also receive pertuzumab. Progression-free survival (PFS) is the primary endpoint. Overall survival, PFS, safety, and tolerability are secondary endpoints. Researchers plan to analyze HER1, -2, and -3 receptor status and downstream markers.

Sponsor: Hoffmann-LaRoche

ClinicalTrials.gov Identifier: NCT01026142


Phase II study of iniparib in breast cancer that has metastasized

Researchers plan to recruit 40 patients with triple-negative breast cancer (TNBC), which has metastasized to the brain, to evaluate the safety and efficacy of iniparib plus irinotecan. TNBC patients with brain metastases experience poor survival rates. The researchers are accepting patients with brain metastases that measure more than 0.5 cm, even if they have already received therapy with iniparib or steroids. However, those with leptomeningeal disease will be excluded. Cohort 1 will be those with new and/or progressive brain metastases following radiation of the central nervous system (CNS). Cohort 2 will be asymptomatic patients who have not received CNS radiotherapy. Patients will receive irinotecan before iniparib. Researchers will use MRI and CT scans to determine the presence of intra- and extracranial disease. Time to progression is the primary endpoint. Secondary endpoints include CNS and non-CNS response rates, progression-free survival, overall survival, quality of life, and correlative science endpoints.

Sponsor: sanofi-aventis

ClinicalTrials.gov Identifier: NCT01173497


PARP inhibition among patients with TNBC

The Hoosier Oncology Group is conducting a multicenter, randomized, phase II trial of cisplatin alone or cisplatin with the experimental compound PF 01367338 among patients with triple-negative breast cancer (TNBC) who have not achieved pathologic complete response (pCR) on anthracyclineand/ or taxane-containing neoadjuvant chemotherapy. The 2-year disease-free survival (DFS) of TNBC patients with residual disease category II or III is poor,%u2015only about 40%. There are no standard systemic therapies for this high-risk group. The researchers chose cisplatin because of its DNA-damaging properties. Cisplatin and PF 01367338 appear to affect the PARP breast cancer cells; they inhibit the replication of DNA and their growth. After completing standard radiation therapy, patients will be randomized to cisplatin alone or with PF 01367338. The primary endpoint is 2-year DFS. Secondary endpoints include safety, 1-year DFS, overall survival, and biomarkers of tumor recurrence, resistance to chemotherapy and/or PARP inhibition. The estimated enrollment is 135 patients.

Sponsor: Hoosier Oncology Group and Pfizer

ClinicalTrials.gov Identifier: NCT01074970


Gastrointestinal Cancer

Phase II trial of FOLFOX with or without vismodegib in advanced gastrointestinal cancer

Researchers are recruiting for a multicenter, phase II study of FOLFOX with or without GDC-0449 (vismodegib) in treatment-naïve patients with advanced gastric and gastroesophageal (GE) junction carcinoma. This randomized, double-blind study will review the efficacy and safety of vismodegib plus FOLFOX versus FOLFOX alone as first-line treatment for advanced GE cancers. The hedgehog (Hh) pathway is critical in the development of both normal and malignant gastroesophageal cell growth and survival, but Hh overexpression correlates with clinical and histological features of GE tumors. Vismodegib, an oral Hh antagonist, binds to and inhibits SMO (Smoothened), a key component of the Hh pathway. By inhibiting SMO, Hh signal transduction is blocked. Patients will receive FOLFOX (leucovorin calcium, fluorouracil, oxaliplatin) with either vismodegib or placebo. Progression free survival is the primary endpoint. Secondary endpoints are overall survival, relative risk, and toxicity rates. The estimated enrollment is 116 patients. As of June 2011, the researchers had enrolled 58 patients.

Sponsor: New York Cancer Consortium and National Cancer Institute

ClinicalTrials.gov Identifier: NCT00982592



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