Sunitinib in Treating Patients With Metastatic Pancreatic Cancer That Progressed After First-Line Therapy With Gemcitabine

NCT00397787 | Completed Phase 2

• 3 other identifiers: NCI-2012-02823CALGB-80603U10CA031946
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial is studying how well sunitinib works in treating patients with metastatic pancreatic cancer that progressed after first-line therapy with gemcitabine. Sunitinib may stop the growth of pancreatic cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth.

Conditions

Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage IV Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

• Response (CR/PR/stable disease) as measured by RECIST criteria

  At 6 weeks post-initiation of protocol treatment

Secondary Outcomes (4)

• Response duration

  Up to 2 years

• Progression-free survival (PFS)

  Up to 2 years

• Number and percentage of patients reporting common and serious adverse events (AEs), the AEs related to sunitinib, reason for study discontinuation, clinically significant laboratory abnormalities, and AEs with worst NCI CTCAE grade

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

Study Arms (1)

Treatment (sunitinib malate)

EXPERIMENTAL

Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib, Sutent

Treatment (sunitinib malate)

Eligibility Criteria

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

You may qualify if:

• Histologic or cytologic documentation of pancreatic adenocarcinoma with evidence of disease progression following first-line therapy is required
• No brain metastases
• Patients with measurable disease
• Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded as \>= 20 mm with conventional techniques or as\>= 10 mm with spiral computed tomography (CT) scan; of particular note, the primary pancreatic tumor does not constitute measurable disease; therefore, patients with locally advanced pancreatic cancer as the sole site of disease are not eligible
• Patients must have received one of the following prior therapies containing gemcitabine:
• One and only one prior therapy for metastatic disease with gemcitabine, or a gemcitabine-containing cytotoxic combination, or
• One prior chemoradiation therapy containing gemcitabine for inoperable locally advanced pancreatic cancer, as long as the patient has subsequently progressed and has measurable disease outside a radiation port, or
• One prior adjuvant chemotherapy regimen or chemoradiation therapy containing gemcitabine if the patient subsequently progressed within 3 months of completion of adjuvant therapy; patients who have received chemoradiation in the adjuvant setting must have measurable disease outside the radiation port
• No prior therapy with any other antiangiogenic agent (e.g., bevacizumab, sorafenib, pazopanib, AZD2171, PTK787, VEGF Trap, etc.)
• At least 4 weeks must have elapsed prior to initiation of treatment since the completion of chemotherapy and/or radiation therapy
• At least 4 weeks must have elapsed prior to registration since any major surgery
• Prior erlotinib is permitted; the last dose must have been administered 14 or more days prior to initiation of treatment; all erlotinib related side effects must have resolved to \< grade 1 prior to registration
• No significant cardiac disease including:
• QTc prolongation (defined as a QTc interval equal to or greater than 500 msec) or other significant EKG abnormalities
• History of myocardial infarction, cardiac arrhythmia, stable/unstable angina, symptomatic congestive heart failure, or coronary/peripheral artery bypass graft or stenting within 12 months prior to registration

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (2)

Cancer and Leukemia Group B

Chicago, Illinois, 60606, United States

Location

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Related Publications (1)

• O'Reilly EM, Niedzwiecki D, Hall M, Hollis D, Bekaii-Saab T, Pluard T, Douglas K, Abou-Alfa GK, Kindler HL, Schilsky RL, Goldberg RM; Cancer and Leukemia Group B. A Cancer and Leukemia Group B phase II study of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma (CALGB 80603). Oncologist. 2010;15(12):1310-9. doi: 10.1634/theoncologist.2010-0152. Epub 2010 Dec 10.

  PMID: 21148613 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Eileen O'Reilly

  Cancer and Leukemia Group B

  PRINCIPAL INVESTIGATOR

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 9, 2006
• First Posted: November 10, 2006
• Study Start: November 1, 2006
• Primary Completion: September 1, 2007
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (2)