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

NCT ID: NCT00462553

Last Updated: 2014-02-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31

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.

Detailed Description

PRIMARY OBJECTIVES:

I. Determine the maximum tolerated dose (MTD) of sunitinib malate and gemcitabine hydrochloride in patients with adenocarcinoma of the pancreas or other solid tumors.

II. Determine the toxicity of this regimen in these patients.

OUTLINE: This is a dose-escalation study.

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.

Cohorts of 3-6 patients receive escalating doses of gemcitabine hydrochloride and sunitinib malate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Up to 10 patients may be treated at the recommended phase II dose (RPTD), which is generally the dose level below the maximally administered dose.

After completion of study treatment, patients are followed for 30 days and then periodically thereafter.

Conditions

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm I

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.

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Given orally

gemcitabine hydrochloride

Intervention Type: DRUG

Given IV

Interventions

sunitinib malate

Given orally

Intervention Type: DRUG

gemcitabine hydrochloride

Given IV

Intervention Type: DRUG

Other Intervention Names

SU11248; sunitinib; Sutent; dFdC; difluorodeoxycytidine hydrochloride; gemcitabine; Gemzar

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Smitha Krishnamurthi

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University

Locations

Case Western Reserve University

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

NCI-2009-00212

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000539459

Identifier Type: -

Identifier Source: secondary_id

CASE 3206

Identifier Type: -

Identifier Source: secondary_id

CASE 3206

Identifier Type: OTHER

Identifier Source: secondary_id

7731

Identifier Type: OTHER

Identifier Source: secondary_id

U01CA062502

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2009-00212

Identifier Type: -

Identifier Source: org_study_id