ASCO Highlights: Trials in Progress

Published: Tuesday, Aug 23, 2011
The Trials in Progress Poster Session (TPS), which was held at the ASCO meeting in June and is now in its second year, is intended to stimulate discussion in the oncology community about ongoing clinical trials and to promote collaboration. The following is a roundup of TPS abstracts that feature trials open to patients aged ≥18 years with a broad range of cancer types.

Brain Cancer

Radiation therapy plus temozolomide with cilengitide or cetuximab in poor-prognosis glioblastoma

This phase II study will determine the effect of radiation therapy (RT) plus temozolomide (TMZ) combined with cilengitide or cetuximab in patients with newly diagnosed glioblastoma multiforme (GBM) with an unmethylated promoter of the O6-methylguanine-DNA-methyltransferase (MGMT) gene. An unmethylated MGMT-promoter is associated with a notoriously poor prognosis. All participants will receive postoperative RT with daily concomitant TMZ followed by adjuvant TMZ, and will then be randomized to additional treatment with either the integrin inhibitor cilengitide or the monoclonal epidermal growth factor receptor (EGFR)-targeted antibody cetuximab. The primary endpoint is the 1-year overall survival (OS). Secondary endpoints include progression-free survival (PFS) and safety. Abstract TPS134.

Sponsor: Merck identifier: NCT01044225

RO4929097 for recurrent/progressive glioblastoma

This phase II pharmacodynamic study will assess the efficacy of the oral gamma secretase inhibitor RO4929097 for the treatment of recurrent or progressive GBM and will also include biomarker assays on freshly resected GBM samples from patients receiving this agent. The primary objectives of the 60-patient study are to determine 6-month PFS in patients treated with RO4929097 and the efficiency of neurosphere generation after RO4929097 pretreatment. Abstract TPS135.

Sponsor: National Cancer Institute ID: NCT01122901

Efficacy of bevacizumab added to treatment standard in newly diagnosed glioblastoma

This phase III study will determine whether adding bevacizumab to standard-of-care treatment involving TMZ chemotherapy and radiotherapy will provide clinical benefit and a treatment advantage for patients with newly diagnosed supratentorial GBM. Coprimary endpoints are investigator-assessed PFS and OS. Secondary endpoints include independent radiology review-assessed PFS, 1- and 2-year survival rates, safety, and health-related quality of life (QOL). Neurocognitive function, signs and symptoms of disease, Karnofsky performance score, and patterns of disease progression will also be analyzed. Abstract TPS136.

Sponsor: F. Hoffmann-La Roche and Genentech ID: NCT00943826

Breast Cancer

Trastuzumab-DM1 (T-DM1) with or without pertuzumab versus trastuzumab plus a taxane for first-line treatment of metastatic breast cancer

This global phase III study will evaluate the efficacy and safety of T-DM1 with or without pertuzumab compared with trastuzumab plus either docetaxel or paclitaxel in women with human epidermal growth factor receptor 2 (HER2)-positive, progressive or recurrent locally advanced or metastatic breast cancer (MBC). T-DM1 is a unique antibody-drug conjugate that combines the antitumor activities of trastuzumab with intracellular delivery of the highly potent cytotoxic agent DM1 (derivative of maytansine). T-DM1 plus pertuzumab has demonstrated synergistic antitumor effects in preclinical models, and preliminary phase Ib/II trial results showed acceptable tolerability and promising efficacy in patients with MBC. The primary endpoint is PFS by independent review facility. Secondary endpoints include safety, overall response rate (ORR), OS, duration of response, and QOL. Thus far, 141 patients have been enrolled and the target recruitment is 1092 patients. The MARIANNE study is the first phase III study to evaluate the combination of a targeted antibody and an antibody-drug conjugate for first-line MBC. The systemic chemotherapy-sparing combination has the potential to establish a new treatment paradigm by optimizing efficacy while minimizing toxicity. Abstract TPS102.

Sponsor: F. Hoffmann-La Roche ID: NCT01120184

Metformin in early-stage breast cancer

This phase III trial will randomize women with early-stage breast cancer to treatment with metformin 850 mg by mouth twice daily or placebo twice daily for 5 years. Metformin is a biguanide used to treat type 2 diabetes that has been shown in epidemiologic, clinical, and preclinical studies to decrease breast cancer risk and improve breast cancer outcomes. The primary endpoint is invasive disease-free survival (DFS). Secondary endpoints include OS, distant DFS, breast cancer-free survival, adverse events, new diabetes, cardiovascular hospitalizations, body mass index, insulin resistance syndrome attributes by Adult Treatment Panel (ATP) III criteria, QOL, diet, and physical activity. The study plans to enroll 3582 women. Abstract TPS103.

Sponsor: National Cancer Institute ID: NCT01101438

Celecoxib for primary breast cancer

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