May 2012: Trials in Progress

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.

Gastrointestinal Cancer

Selenium for prevention of colorectal polyps

This phase III trial is testing the efficacy of the dietary supplement selenium for preventing recurrent adenomatous colorectal polyps. Patients will be randomized to once-daily oral selenium at a dose of 200 mcg for 3 to 5 years, depending on the surveillance colonoscopy recommendation. The primary outcome measure is the recurrence of colorectal adenomatous polyps in relation to histologic type, degree of dysplasia, number, size, and location. The researchers will also compare the type, incidence, and outcome of side effects with the 2 regimens and assess adherence to long-term treatment. The study aims to initially enroll 1600 patients with adenoma, followed by a second group of 200 patients with at least one advanced adenoma (at baseline) in a substudy.

Sponsor: University of Arizona

ClinicalTrials.gov Identifier: NCT00078897

ABI-007 added to standard treatment versus standard treatment alone for pancreatic cancer

This phase III study will compare ABI-007 (albuminbound paclitaxel) in combination with gemcitabine, administered weekly, to standard treatment involving gemcitabine monotherapy in patients with metastatic adenocarcinoma of the pancreas. The experimental arm will receive ABI-007 125 mg/m2 administered in combination with gemcitabine 1000 mg/m2 weekly for 3 weeks followed by 1 week of rest. The active comparator arm will receive gemcitabine 1000 mg/m2 administered weekly for 7 weeks followed by a week of rest (cycle 1), followed by cycles of weekly administration for 3 weeks, followed by a week of rest (cycle 2 onward). The primary outcome measure is overall survival. The investigators, from 180 centers, anticipate a study completion date of October 2014.

Sponsor: Celgene Corporation

ClinicalTrials.gov Identifier: NCT00844649

Head and Neck Cancer

Doxepin hydrochloride for oral mucositis pain

This phase III study is comparing doxepin hydrochloride mouth rinse versus placebo for the treatment of oral mucositis pain in patients with head and neck cancer who are undergoing radiation therapy with or without chemotherapy. Patients are randomized to briefly swish, gargle, and spit out the active mouth rinse or placebo on day 1, and they may cross over to the alternate arm on day 2. Primary outcome measures include total pain reduction in the mouth and throat. Secondary endpoints include total taste of the oral rinse, total stinging or burning from the oral rinse, total drowsiness increase, incidence of using alternative analgesics 4 hours before and in between study medications, patient preference for continuing therapy with oral doxepin hydrochloride, pain reduction and other adverse-event profile in the optional blinded crossover phase, and long-term outcome of doxepin hydrochloride oral rinse as measured by weekly questionnaire responses.

Sponsor: North Central Cancer Treatment Group

ClinicalTrials.gov Identifier: NCT01156142

Timing of swallowing exercises in head and neck cancer patients

This phase III study is comparing early onset versus late onset of swallowing exercise therapy in patients undergoing chemotherapy or radiation therapy for head and neck cancer. The primary outcome measure is the MD Anderson Dysphagia Inventory (MDADI) swallowing quality-of-life score at 1, 3, 6, and 12 months following completion of radiotherapy. Patients randomized to the early-exercise group perform swallowing exercises for 2 weeks prior to beginning radiotherapy, and again immediately after the completion of radiotherapy, while patients assigned to the late-exercise group begin swallowing exercises 1 month after the completion of radiotherapy. Swallowing exercises include lingual press, head lift, breath hold, Masako swallow, maintaining a highpitched sound, performing effortful swallows, and neck stretch and massage.

Sponsor: Wake Forest University

ClinicalTrials.gov Identifier: NCT01053546

Lymphoma

Bendamustine with or without GA101 in non-Hodgkin lymphoma

This phase III study is examining the efficacy and safety of bendamustine compared with bendamustine+RO5072759 (GA101) in patients with rituximab-refractory, indolent non-Hodgkin lymphoma. GA101 is an investigational glycoengineered, type II, humanized anti-CD20 monoclonal antibody. The primary outcome measure is progression-free survival. Secondary outcome measures include overall survival, complete response, overall response, and best response. Overall, 127 centers are participating in the study, which has a target recruitment of 360 patients.

Sponsor: Genentech

ClinicalTrials.gov Identifier: NCT01059630

Brentuximab vedotin for residual Hodgkin lymphoma after stem cell transplant

This phase III study is evaluating the efficacy and safety of brentuximab vedotin and best supportive care (BSC) compared with placebo and BSC in the treatment of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT). Investigators plan to randomize 322 patients to the antibody-drug conjugate brentuximab vedotin or placebo administered every 21 days by IV infusion (1.8 mg/kg). The primary outcome measure is progression-free survival. Secondary outcome measures are overall survival, the incidence of adverse events and laboratory abnormalities, and the incidence of anti-therapeutic antibodies to brentuximab vedotin. The estimated study completion date is April 2016.

Sponsor: Seattle Genetics, Inc.

ClinicalTrials.gov Identifier: NCT01100502

Skin Cancer

Ipilimumab or high-dose interferon alfa-2b for melanoma

This phase III study is comparing adjuvant ipilimumab anti-CTLA4 therapy versus high-dose interferon alpha-2b in patients with high-risk stage III or IV resected melanoma. Patients are stratified according to American Joint Committee on Cancer Staging (IIIB vs IIIC vs M1a vs M1b) and randomized to receive induction high-dose ipilimumab, low-dose ipilimumab, or high-dose recombinant interferon alfa-2b. After the completion of therapy, patient follow-up will occur every 3 months for 2 years, every 6 months for 3 years, and then yearly for 15 years. Primary outcome measures are recurrencefree survival and overall survival. Secondary outcome measures are toxicity of adjuvant ipilimumab (at high and low dosages) versus highdose recombinant interferon alfa-2b and global quality of life. Investigators plan to enroll 1500 patients at 284 study sites.

Sponsor: Eastern Cooperative Oncology Group

ClinicalTrials.gov Identifier: NCT01274338

An immunotherapeutic as adjuvant therapy for resected melanoma

This phase III study is assessing the benefit of GSK 2132231A antigen-specific cancer immunotherapeutic for preventing relapse in patients with melanoma after surgical removal of their tumor. Patients are randomized to 13 injections of the investigational immunotherapeutic or placebo, to be administered over 27 months. The primary outcome measure is disease-free survival. Secondary outcome measures are overall survival, disease-free-specific survival, distant metastasisfree survival, anti-MAGE-A3 and anti-protein D seropositivity status, the occurrence of adverse events including abnormal hematological and biochemical parameters, the occurrence of serious adverse events and autoimmunity events, and health-related quality-of-life assessment using the EuroQoL 5D (EQ-5D) questionnaire.

Sponsor: GlaxoSmithKline

ClinicalTrials.gov Identifier: NCT00796445