Selumetinib in Treating Patients With Biliary Cancer That Cannot Be Removed By Surgery

NCT00553332 | Completed Phase 2 Results

• 6 other identifiers: NCI-2009-00251OSU 07056OSU-07056CDR0000573452N01CM62208N01CM62207
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 7

Brief Summary

This phase II trial is studying how well selumetinib works in treating patients with biliary cancer that cannot be removed by surgery. Selumetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Conditions

Liver and Intrahepatic Biliary Tract Cancer; Recurrent Extrahepatic Bile Duct Cancer; Unresectable Extrahepatic Bile Duct Cancer

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (CR and PR)

  Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR

  Every 8 weeks

Secondary Outcomes (5)

• Toxicity Profile of AZD6244

  From the time of first treatment with AZD6244, assessed up to 4 weeks

• Median Progression Free Survival for Patients

  Up to 6 months

• Overall Survival

  Up to 12 months

• RAS/RAF/MEK/ERK Signaling Pathway Activation

  At baseline

• Protein Levels of RAS/RAF/MEK/ERK Signaling Pathway Activation

  At baseline

Study Arms (1)

Treatment (enzyme inhibitor therapy)

EXPERIMENTAL

Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: selumetinib; Other: laboratory biomarker analysis

Interventions

selumetinib DRUG

Given orally

Also known as: ARRY-142886, AZD6244

Treatment (enzyme inhibitor therapy)

laboratory biomarker analysis OTHER

Correlative studies

Treatment (enzyme inhibitor therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed biliary tract carcinoma
• Surgically unresectable disease
• Meets any of the following criteria for biliary cancers only:
• Received ≤ 1 prior systemic anticancer therapy, including chemoembolization
• Received prior cryotherapy, radiofrequency ablation, ethanol injection, transarterial chemoembolization, or photodynamic therapy AND meets the following criteria:
• More than 6 weeks have elapsed since any of the prior therapy described above
• Indicator lesion(s) must be outside the area of prior treatment OR must demonstrate clear evidence of disease progression if the only indicator lesion is inside the prior treatment area
• Indicator lesion must have clearly distinct edges on CT scan
• Prior radiotherapy with or without the use of a fluoropyrimidine as a radiosensitizer is allowed, provided more than 12 weeks have elapsed since treatment
• Fresh or paraffin-embedded tissue from tumor blocks must be available for review
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion \> 20 mm by conventional techniques or \> 10 mm by spiral CT scan
• No known brain metastases
• Life expectancy \> 12 weeks
• ECOG performance status (PS) 0-1 or Karnofsky PS 70-100%
• ANC ≥ 1,500/μL

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (7)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

University of Michigan Cancer Center (UMCC) Research Base

Ann Arbor, Michigan, 48109-0352, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Ohio State University Medical Center

Columbus, Ohio, 43210, United States

Location

Vanderbilt University

Nashville, Tennessee, 37232, United States

Location

Related Publications (1)

• Bekaii-Saab T, Phelps MA, Li X, Saji M, Goff L, Kauh JS, O'Neil BH, Balsom S, Balint C, Liersemann R, Vasko VV, Bloomston M, Marsh W, Doyle LA, Ellison G, Grever M, Ringel MD, Villalona-Calero MA. Multi-institutional phase II study of selumetinib in patients with metastatic biliary cancers. J Clin Oncol. 2011 Jun 10;29(17):2357-63. doi: 10.1200/JCO.2010.33.9473. Epub 2011 Apr 25.

  PMID: 21519026 RESULT

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Bile Duct Neoplasms

Interventions

AZD 6244

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Biliary Tract Neoplasms; Bile Duct Diseases; Biliary Tract Diseases

Results Point of Contact

• Title: Tanios Bekaii-Saab, MD
• Organization: The Ohio State University Comprehensive Cancer Center-James Cancer Hospital and Solove Research Institute

Tanios.Bekaii-Saab@osumc.edu

614-293-9863

Study Officials

• Tanios Bekaii-Saab

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2007
• First Posted: November 5, 2007
• Study Start: November 1, 2007
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2013
• Last Updated: April 22, 2016
• Results First Posted: April 22, 2016

Record last verified: 2016-03

Locations

US (7)