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

Study Overview

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

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.

PRIMARY OBJECTIVES: I. To determine the response rate to sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma. SECONDARY OBJECTIVES: I. To determine the duration of response, progression-free survival and overall survival of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma. II. To determine the safety of sunitinib malate in patients with previously treated metastatic pancreatic adenocarcinoma. OUTLINE: This is a multicenter, nonrandomized study. Patients receive oral sunitinib malate daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. After completion of study, patients are followed every 3 months until 2 years from study entry or until disease progression.

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

DRUG: sunitinib malate

NCI-2012-02823
CALGB-80603
U10CA031946 (U.S. NIH Grant/Contract)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2006-11-09	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-06-03
First Submitted that Met QC Criteria 2006-11-09	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-06-04
First Posted (ESTIMATED) 2006-11-10	Results First Posted N/A	Last Verified 2013-06

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Treatment (sunitinib malate) 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 Given PO

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Treatment (sunitinib malate)

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

Given PO

Primary Outcome Measures	Measure Description	Time Frame
Response (CR/PR/stable disease) as measured by RECIST criteria		At 6 weeks post-initiation of protocol treatment

Secondary Outcome Measures	Measure Description	Time Frame
Response duration	Duration of response will be determined for the subset of patients who achieve a confirmed response of CR or PR. Duration of objective response will be defined as the time from the first tumor assessment indicating response (later confirmed) to the time of disease progression or death from any cause.	Up to 2 years
Progression-free survival (PFS)	Median and 1-year survival will be assessed using Kaplan-Meier methods.	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	Summarized descriptively for all patients receiving at least one dose of sunitinib.	Up to 2 years
Overall survival (OS)	Median and 1-year survival will be assessed using Kaplan-Meier methods.	Up to 2 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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
History of class III or IV heart failure within 12 months prior to registration as defined by the NYHA functional classification system
In addition, patients with history of hypertension must be well controlled (< 140/90) on a regimen of anti-hypertensive therapy
Patients with a history of hypothyroidism are eligible, provided they are currently euthyroid
The use of inhibitors and inducers of CYP3A4 is not permitted:

The following inhibitors of CYP3A4 is prohibited within 7 days before beginning and during treatment with sunitinib:

Azole antifungals (ketoconazole, itraconazole)
Diltiazem
Clarithromycin
Erythromycin
Verapamil
Delavirdine
HIV protease inhibitors (indinavir, saquinavir, ritonavir, atazanavir, nelfinavir)
The following inducers of CYP3A4 are prohibited within 12 days before beginning and during treatment with sunitinib:

Rifampin
Rifabutin
Carbamazepine
Phenobarbital
Phenytoin
St. John's wort
Efavirenz
Tipranavir
Other inhibitors or inducers of CYP3A4 may be used if necessary, but their use is discouraged
The use of agents with proarrhythmic potential (e.g., quinidine, procainamide, disopyramide, sotalol, probucol, bepridil, haloperidol, risperidone, indapamide, flecainide) is not permitted during the study
ECOG performance status 0-2
No history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to registration
No history of pulmonary embolism within the past 6 months
Patients who require use of therapeutic doses of coumadin-derivative anticoagulants such as warfarin are excluded, although doses of up to 2 mg daily are permitted for prophylaxis of thrombosis; Note: Low molecular weight heparin is permitted provided the patient's PT INR is < 1.5
No serious or non-healing wound, ulcer, or bone fracture
No history (within 6 months) of significant bleeding events (e.g., upper or lower GI bleeding, hemoptysis, or hematuria), abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of treatment
No evidence of duodenal invasion by the tumor on CT scan
No "currently active" second malignancy other than non-melanoma skin cancers; patients are not considered to have a "currently active" malignancy if they have completed therapy and are considered by their physician to be at less than 30% risk of relapse
Non-pregnant and not breast feeding; pregnant women are excluded from this study because sunitinib is an antiangiogenic agent with the potential for teratogenic or abortifacient effects; because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with sunitinib, breastfeeding should be discontinued if the mother is treated with sunitinib malate
ANC >= 1,500/μl
Platelet count >= 100,000/μl
Bilirubin < 1.5 mg/dL
PT and PTT =< 1.5 X ULN
Creatinine =< 1.5 mg/dL
AST (SGOT) =< 2.5 X ULN if no liver metastases (=< 5 X ULN if liver metastases)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Eileen O'Reilly, Cancer and Leukemia Group B

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

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