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A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy


Phase 2
18 Years
N/A
Not Enrolling
Both
Acinar Cell Adenocarcinoma of the Pancreas, Duct Cell Adenocarcinoma of the Pancreas, Recurrent Pancreatic Cancer, Stage IV Pancreatic Cancer

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Trial Information

A Phase II Study of Sunitinib Malate (SU11248, NSC #736511, IND #74,019) in Patients With Previously Treated Pancreatic Adenocarcinoma With Measurable Metastatic Disease Following Progression on Front-Line Gemcitabine-Based Therapy


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.


Inclusion Criteria:



- 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)

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

At 6 weeks post-initiation of protocol treatment

Safety Issue:

No

Principal Investigator

Eileen O'Reilly

Investigator Role:

Principal Investigator

Investigator Affiliation:

Cancer and Leukemia Group B

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2012-02823

NCT ID:

NCT00397787

Start Date:

November 2006

Completion Date:

Related Keywords:

  • Acinar Cell Adenocarcinoma of the Pancreas
  • Duct Cell Adenocarcinoma of the Pancreas
  • Recurrent Pancreatic Cancer
  • Stage IV Pancreatic Cancer
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms
  • Carcinoma, Acinar Cell

Name

Location

Memorial Sloan Kettering Cancer CenterNew York, New York  10021
Cancer and Leukemia Group BChicago, Illinois  60606