October 2011: 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. This month’s collection highlights trials presented at the 2011 American Society of Clinical Meeting [J Clin Oncol. 2011;29(suppl)].

Head and Neck Cancer

Impact of HPV status in prognosis of oropharynx squamous cell carcinoma

Human papillomavirus (HPV)—positive oropharynx squamous cell carcinoma (OSCC) should have a better overall and specific prognosis according to studies, yet there is no evidence-based indication for better treatment methods. In a multicenter study, tumor and serum collections are constituted to analyze virological parameters of HPV-positive tumors, molecular tumor markers, and immunohistochemistry analysis. The primary endpoint is disease-free survival (DFS) at 2 years according to HPV status. Secondary endpoints are overall survival at 2 years, virological characteristics in HPV-positive tumors, and molecular tumor characteristics in HPV-positive tumors compared to HPV-negative tumors. Enrollment began in May 2009. Abstract TPS198.

Sponsor: Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier: NCT00918710

Hematologic Malignancies

Nilotinib in Philadelphia chromosome— positive chronic myeloid leukemia

As tyrosine kinase inhibitors become more potent, more sensitive methods must be used to monitor treatment response, and some of those levels are undetectable by current technology. Newer technologies are needed to detect larger reductions. A multicenter study is ongoing with 300 adults with Philadelphia chromosome-positive (Ph ) chronic myeloid leukemia in chronic phase (CML-CP) who would be treated with 300 mg of nilotinib, a tyrosine kinase inhibitor, twice daily for up to 4 years. BCR-ABL transcripts are quantified using RT-PCR, and an exploratory molecular assay with an additional >1-log sensitivity and mutation detection and quantification will be evaluated. The primary endpoint is the rate of confirmed CMR at 24 months. Abstract TPS204.

Sponsor: Novartis Pharmaceuticals

ClinicalTrials.gov Identifier: NCT00644878

Elacytarabine versus investigator’s choice in refractory acute myeloid leukemia

A phase III trial is underway to determine the efficacy of elacytarabine, a chemical entity developed as an antineoplastic agent, compared to a drug of the investigator’s limited choice in treating patients with refractory acute myeloid leukemia (AML). The open-label, randomized controlled trial is designed to compare the overall survival as well as response rates, duration of response, and safety profile of elacytarabine with the investigator’s choice treatments (ie, HIDAC, MEC, FLAG/FLAG-IDA, low-dose Ara-C, hypomethylating agents, hydroxyurea, or palliative care). The study is expected to enroll 350 patients over 75 sites across the United States. Abstract TPS206.

Sponsor: Clavis Pharma

ClinicalTrials.gov Identifier: NCT01147939

Lung Cancer

Anastrozole and fulvestrant in postmenopausal women with advanced NSCLC

A phase II randomized trial has been designed to test the effectiveness of post-induction consolidation treatment in postmenopausal women with advanced non—small cell lung cancer (NSCLC). Patients will be randomized in a 3-to-1 ratio to receive either anastrozole and fulvestrant (AF) and best supportive care (BSC) or BSC alone. AF treatment consists of anastrozole 1 mg by mouth once daily and fulvestrant 250 mg intramuscularly monthly after a loading dose of 500 mg on day 1 and 250 mg on day 14 of cycle 1, repeated every 4 weeks until disease progression. Abstract TPS212.

Sponsor: University of Pittsburgh

ClinicalTrials.gov Identifier: NCT00932152

Second-line erlotinib versus chemotherapy in NSCLC

PROSE is a phase III, prospective, double-blind trial in which patients with advanced non—small cell lung cancer (NSCLC) are randomized to receive erlotinib 150 mg daily or standard chemotherapy. Erlotinib is a tyrosine kinase inhibitor that acts on EGFR. This study is designed to evaluate the predictive value of the proteomic classifier on outcome in patients with advanced NSCLC treated with EGFR TKIs or standard chemotherapy. Patients will be stratified based on ECOG performance status, smoking history, and proteomic profile. Until now, 196 of the 275 patients planned have been enrolled in 12 Italian centers. Abstract TPS214.

Supportive Care

Evaluation of an e-health intervention for fear of cancer recurrence

E-health interventions with or without the aid of social networking are being analyzed in order to determine their effectiveness in addressing the psychosocial needs of cancer patients fearful of recurrence. The trial is enrolling patients who have had any cancer diagnosis—excluding basal or squamous cell skin cancers—who have completed treatment and are in remission. Patients also must have an ECOG performance status of 0-2, be aged ≥19 years, have no history of psychiatric hospitalization in the last 5 years, and not be currently receiving psychosocial treatment. The e-health intervention is an interactive Website that teaches behavioral management strategies for fatigue, pain, and other side effects. Abstract TPS237.

Sponsor: Northwestern University

ClinicalTrials.gov Identifier: NCT01348997

Safety and efficacy of the DigniCap system in preventing chemotherapyinduced alopecia

The DigniCap system has been designed to cool the scalp in patients undergoing chemotherapy as a means to prevent alopecia by reducing the amount of drug delivered to the scalp. A pilot study is being designed to test its effectiveness in breast cancer patients receiving standard chemotherapy at 2 centers in the United States. Patients with stage I breast cancer receiving chemotherapy with a taxane or an anthracycline are eligible. Photographs of the hair and scalp are taken at baseline at each chemotherapy cycle and at 3, 6, and 12 months after the end of chemotherapy. Abstract TPS244.

Women’s Cancer

Benefit of palliative chemotherapy in platinum-resistant or platinumrefractory ovarian cancer

A study is enrolling patients with platinum-resistant or platinum-refractory ovarian cancer (PRR ROC) to measure the benefit from palliative chemotherapy that can be used in clinical trials in these patients. The prospective observation cohort will focus on women with PRR ROC who are about to begin palliative chemotherapy. Stage 2 of the cohort will assess their quality of life scores from baseline to posttreatment assessment as well as a new measure of symptoms, the Measure of Ovarian Cancer Symptoms and Treatment Concerns (MOST). Both measures will be summarized by standard descriptive statistical measures. Relative changes from baseline will also be examined. Abstract TPS241.