Clinical 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

Capecitabine or observation after surgery for biliary tract cancer

This phase III study is comparing adjuvant chemotherapy with capecitabine versus expectant treatment alone following surgery for biliary tract cancer. Study participants are stratified according to surgical center, disease site (hilar/extrahepatic cholangiocarcinoma vs intrahepatic cholangiocarcinoma vs gallbladder vs intrapancreatic/common bile duct), type of resection (R0 vs R1), and ECOG performance status (0 vs 1 vs 2). Afterward, they are randomized to observation only or to treatment with oral capecitabine twice a day on days 1-14, with treatment repeated every 3 weeks for eight courses in the absence of disease progression or unacceptable toxicity. The primary outcome measure is survival at 2 years. Secondary outcome measures are survival at 5 years, relapse-free survival, toxicity, quality of life, and cost-effectiveness. The investigators aim to recruit 360 patients.

Sponsor: Southampton University Hospitals NHS Trust

ClinicalTrials.gov Identifier: NCT00363584

Oral Cancer

Radiation therapy with cisplatin or cetuximab in oropharyngeal cancer

This phase III study will compare radiotherapy plus cetuximab versus chemoradiotherapy in oropharynx cancer associated with human papillomavirus. Approximately 706 patients will be randomized at 143 study sites to one of two treatment regimens. One group of patients will undergo image-guided, intensity-modulated radiation therapy (IMRT) once daily on days 1-4 and twice daily on day 5 weekly for 6 weeks; they will also receive high-dose cisplatin administered intravenously (IV) over 1-2 hours on days 1 and 22. The other group will receive cetuximab IV over 2 hours starting 1 week prior to IMRT, and will then receive cetuximab IV over 1 hour once weekly for 7 weeks; they will also undergo IMRT using the same protocol as the comparator group. The primary outcome measure is 5-year overall survival. Secondary outcome measures are progression-free survival (PFS), locoregional failure, distant metastasis, acute toxicities, overall toxicity burden at the end of treatment and at 1, 3, and 6 months after the completion of treatment, and late toxicities at 1, 2, and 5 years.

Sponsor: Radiation Therapy Oncology Group

ClinicalTrials.gov Identifier: NCT01302834

Erlotinib for prevention of oral cancer

This phase III study will test the ability of erlotinib to prevent oral cancer in the high-risk setting of oral leukoplakia with loss of heterozygosity (LOH) in two patient cohorts. One cohort includes patients with oral intraepithelial neoplasia (IEN) with LOH in 3p and/or 9p and one other specific chromosomal locus but without cancer. The other cohort includes oral IEN patients with LOH in chromosome 3p and/or 9p associated with curatively treated oral cancer. About 150 patients will be randomized to 12-month treatment with 150 mg of oral erlotinib daily or placebo. The primary outcome measure is oral cancer—free survival in patients receiving erlotinib compared with the control group. The investigators also intend to assess the size, number, and appearance of oral IEN lesions and correlate the findings with cancer risk, examine erlotinib-associated toxicity, and evaluate a panel of molecular markers for correlations with oral cancer development in patients with oral IEN. The study’s estimated primary completion date is November 2014.

Sponsor: MD Anderson Cancer Center

ClinicalTrials.gov Identifier: NCT00402779

Head and Neck Cancer

Radiation therapy plus cisplatin with or without 5-fluorouracil for head and neck cancer

This phase III study will test cisplatin alone or the combination of 5-fluorouracil and cisplatin concurrent with radiotherapy in patients with stage III or IV squamous cell head and neck cancer. Patients are stratified according to radiotherapy schedule (once daily vs twice daily) and radiotherapy planning (2D vs 3D vs intensity-modulated radiotherapy), and then randomized to one of two treatment arms. One group of patients will undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. The other group will undergo radiotherapy as in the other treatment arm and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy. Patients with biopsy-verified residual disease at the primary site or local recurrence after achieving a complete response to chemoradiotherapy may undergo salvage surgery 12 weeks after the completion of chemoradiotherapy. The primary outcome measure is clinical response defined as the complete disappearance of detectable tumor at 12 weeks after completing chemoradiotherapy. Overall, about 126 patients will be recruited for the study, which has an estimated primary completion date of February 2013.

Sponsor: Case Comprehensive Cancer Center

ClinicalTrials.gov Identifier: NCT00608205

Brain Cancer

Radiation therapy and carmustine with or without O6BG in glioblastoma multiforme or gliosarcoma

This phase III trial is comparing the effectiveness of radiation therapy plus carmustine with or without O6-benzylguanine (O6BG) in patients with newly diagnosed glioblastoma multiforme or gliosarcoma. Subjects are stratified by age (<50 years vs ≥50 years), prior surgery (biopsy only vs resection), and Zubrod performance status (0-1 vs 2), and then randomized to one of two treatment arms. One group of patients will undergo radiotherapy daily 5 days a week over 7 weeks for a total of 34 fractions, and also receive chemotherapy involving O6BG IV over 1 hour followed 6 hours later by carmustine IV over 1 hour on day 1 of radiotherapy; chemotherapy is repeated every 6 weeks for a maximum of seven courses in the absence of disease progression or unacceptable toxicity. Patients in the comparator arm undergo radiotherapy and receive carmustine IV using the same protocol as the other treatment group. The primary outcome measure is overall survival. Secondary outcome measures are PFS, time to treatment failure, and toxicity. There are 183 patients enrolled in the study.

Sponsor: Southwest Oncology Group

ClinicalTrials.gov Identifier: NCT00017147

Radiation therapy with or without temozolomide for older patients with glioblastoma multiforme

This phase III study will compare treatment with temozolomide and short-course radiation versus short-course radiation alone in elderly patients with newly diagnosed glioblastoma multiforme. Subjects will be stratified according to center, age (65-70 years vs 71-75 years vs ≥76 years), ECOG performance status (0-1 vs 2), and extent of resection at surgery (biopsy only vs complete or incomplete resection), and then randomized to one of two treatment groups. One group of patients will undergo radiotherapy once daily on days 1-5, 8-12, and 15-19 in the absence of disease progression or unacceptable toxicity. The other group will undergo radiotherapy as in the other treatment arm and receive oral temozolomide once daily on days 1-21. The primary outcome measure is overall survival. Secondary outcome measures are PFS, adverse events, quality of life, and methylation status of the O6-methylguanine-DNA methyltransferase promoter. Target enrollment is 560 patients.

Sponsor: NCIC Clinical Trials Group

ClinicalTrials.gov Identifier: NCT00482677