Sunitinib and Gemcitabine in Treating Patients With Pancreatic Cancer or Other Solid Tumors

NCT00462553 | Completed Phase 1

• 5 other identifiers: NCI-2009-00212CDR0000539459CASE 32067731U01CA062502
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

This phase I trial is studying the side effects and best dose of sunitinib and gemcitabine in treating patients with pancreatic cancer or other solid tumors. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Drugs used in hemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving sunitinib together with gemcitabine may kill more tumor cells.

Conditions

Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage III Pancreatic Cancer; Stage IV Pancreatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Maximum tolerated dose (MTD) determined according to dose-limiting toxicities (DLTs) graded using Common Terminology Criteria for Adverse Events

  28 days

Secondary Outcomes (2)

• Response rate assessed by Response Evaluation Criteria for Solid Tumors (RECIST)

  Up to 3 years

• Overall survival

  Up to 3 years

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 OR on days 1, 8, and 15. Patients also receive oral sunitinib malate once daily on days 1-21 OR days 1-28. Treatment repeats every 21 days OR every 28 days in the absence of disease progression or unacceptable toxicity.

Drug: sunitinib malate; Drug: gemcitabine hydrochloride

Interventions

sunitinib malate DRUG

Given orally

Also known as: SU11248, sunitinib, Sutent

Arm I

gemcitabine hydrochloride DRUG

Given IV

Also known as: dFdC, difluorodeoxycytidine hydrochloride, gemcitabine, Gemzar

Arm I

Eligibility Criteria

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

Criteria: * Histologically or cytologically confirmed pancreatic adenocarcinoma OR other solid tumor: * Not amenable to curative therapy * Previously untreated metastatic pancreatic adenocarcinoma allowed * Measurable or evaluable disease * No history of or known brain metastases, spinal cord compression, carcinomatous meningitis, or new evidence of brain or leptomeningeal disease on screening CT scan or MRI scan * ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100% * Life expectancy \>= 12 weeks * Absolute neutrophil count \>= 1,500/mm3 * Platelet count \>= 100,000/mm3 * Hemoglobin \>= 8.5 g/dL * Bilirubin =\< 1.5 mg/dL * Creatinine normal OR creatinine clearance \>= 60 mL/min * AST and ALT =\< 2.5 times upper limit of normal (ULN) (=\< 5 times ULN if due to underlying disease) * Calcium =\< 12.0 mg/dL * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for at least 6 months after completion of study therapy * LVEF normal by MUGA scan or ECHO at baseline * Deep venous thrombosis or pulmonary embolism allowed provided they are clinically stable and adequately treated * No preexisting thyroid abnormality that results in the inability to maintain thyroid function in the normal range while using medication * No history of allergic reactions attributed to compounds of similar chemical or biological composition to sunitinib malate * No history of any of the following within the past 6 months: * Myocardial infarction * Ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation \>= 3 beats in a row) * Severe/unstable angina * Severe peripheral vascular disease (i.e., claudication) * Procedure on peripheral vasculature * Coronary/peripheral artery bypass graft * Cerebrovascular accident * No history of any of the following within the past 6 months: * Transient ischemic attack; * Clinically significant bleeding requiring red blood cell transfusion * No NYHA class III or IV heart disease: * Patients with NYHA class II disease who are stable and on medication are eligible * No ongoing cardiac dysrhythmias \>= grade 2, atrial fibrillation of any grade, or any significant EKG abnormalities * No hypertension that cannot be controlled by medications to a systolic blood pressure (BP) of \< 140 mm Hg and diastolic BP of \< 90 mm Hg * No condition that impairs the ability to swallow and retain sunitinib malate tablets, including any of the following: * Gastrointestinal tract disease resulting in an inability to take oral medication * Requirement for IV alimentation * Prior surgical procedures affecting absorption * Active peptic ulcer disease * No gastrointestinal perforation or intra-abdominal abscess within the past 28 days * No serious nonhealing infection or bone fracture * No other severe acute or chronic medical condition, psychiatric condition, or laboratory abnormality that would preclude study therapy * May have received any number of prior systemic therapies * More than 4 weeks since prior radiotherapy or surgery and recovered * More than 4 weeks since other prior therapies and recovered * Prior gemcitabine hydrochloride allowed * No prior sunitinib malate or other therapy directed against VEGF, including any of the following: Sorafenib; Bevacizumab; Vatalanib; AZD2171; VEGF Trap; Investigational antiangiogenic therapy * More than 7 days since prior and no concurrent CYP3A4 inhibitors, including any of the following: * Ketoconazole * Itraconazole * Clarithromycin * Erythromycin * Diltiazem * Verapamil * Indinavir * Ritonavir * Nelfinavir * Saquinavir * Atazanavir * Delavirdine * More than 12 days since prior and no concurrent CYP3A4 inducers, including any of the following: * Rifampin * Rifabutin * Carbamazepine * Phenobarbital * Phenytoin * Hypericum perforatum (St. John's wort) * Efavirenz * Tipranavir * No concurrent agents with proarrhythmic potential, including any of the following: * Terfenadine * Quinidine * Procainamide * Disopyramide * Sotalol * Probucol * Bepridil * Haloperidol * Risperidone * Indapamide * Flecainide * No concurrent combination antiretroviral therapy for HIV-positive patients * No concurrent treatment on another clinical trial: Participation in non-therapeutic clinical trials allowed * QTc \< 500 msec

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

Case Western Reserve University

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Sunitinib; Gemcitabine

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; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Smitha Krishnamurthi

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2007
• First Posted: April 19, 2007
• Study Start: March 1, 2007
• Primary Completion: June 1, 2010
• Last Updated: February 24, 2014

Record last verified: 2013-04

Locations

US (1)