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Status:

COMPLETED

AZD0530 and Gemcitabine in Locally Advanced/Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery

Lead Sponsor:

NCIC Clinical Trials Group

Collaborating Sponsors:

AstraZeneca

Conditions:

Pancreatic Cancer

Eligibility:

All Genders

18-120 years

Phase:

PHASE1

PHASE2

Brief Summary

RATIONALE: AZD0530 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth...

Detailed Description

OBJECTIVES: Phase I * Determine the maximum tolerated dose of AZD0530 when given in combination with gemcitabine in patients with unresectable, locally advanced or metastatic pancreatic cancer. * De...

Eligibility Criteria

Inclusion

  • DISEASE CHARACTERISTICS:
  • Histologically or cytologically confirmed pancreatic adenocarcinoma
  • Unresectable disease
  • Locally advanced or metastatic disease
  • Clinically or radiologically documented disease
  • Measurable or evaluable disease (phase I)
  • Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan (phase II)
  • Measurable lesion must be outside of previously irradiated field if it is the sole site of disease unless there is documented disease progression
  • No known brain metastases
  • PATIENT CHARACTERISTICS:
  • Performance status
  • ECOG 0-2
  • Life expectancy
  • More than 12 weeks
  • Hematopoietic
  • Platelet count ≥ 100,000/mm\^3
  • Absolute granulocyte count ≥ 1,500/mm\^3
  • Hepatic
  • Bilirubin normal
  • AST and ALT ≤ 2 times upper limit of normal (ULN) (5 times ULN if clearly attributable to liver metastasis)
  • Renal
  • Creatinine normal
  • Cardiovascular
  • No active cardiomyopathy
  • No congestive heart failure
  • No unstable angina pectoris
  • No cardiac arrhythmia
  • No uncontrolled hypertension
  • No myocardial infarction within the past 12 months
  • Pulmonary
  • No pulmonary disease requiring oxygen supplementation
  • Gastrointestinal
  • Must not require IV hyperalimentation
  • No uncontrolled inflammatory gastrointestinal (GI) disease (e.g., Crohn's disease or ulcerative colitis)
  • No active peptic ulcer disease
  • No postsurgical malabsorption characterized by uncontrolled diarrhea that results in weight loss and vitamin deficiency
  • No other GI tract disease resulting in an inability to take oral medications
  • Must be able to take oral medication without crushing, dissolving, or chewing tablets
  • Pancreatic enzyme supplementation allowed provided the above conditions are met
  • Immunologic
  • No immune deficiency
  • No active, uncontrolled, or serious infection
  • No know hypersensitivity to study drugs or their components
  • No known HIV positivity
  • Other
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of psychiatric illness (e.g., uncontrolled psychotic disorders) or neurologic disorder that would preclude study compliance
  • No other serious medical condition or illness that would preclude study participation
  • No other malignancy within the past 5 years except curatively treated nonmelanomatous skin cancer or carcinoma in situ of the cervix or bladder
  • PRIOR CONCURRENT THERAPY:
  • Chemotherapy
  • No prior chemotherapy except fluorouracil (with or without leucovorin calcium) or gemcitabine given concurrently with radiotherapy as a radiosensitizer
  • At least 4 weeks since prior fluorouracil or gemcitabine
  • Endocrine therapy
  • Concurrent systemic hormonal therapy for symptom control (e.g., appetite stimulation, pain, or nausea) allowed
  • Radiotherapy
  • See Disease Characteristics
  • See Chemotherapy
  • At least 4 weeks since prior radiotherapy for local disease and recovered
  • Surgery
  • At least 3 weeks since prior major surgery
  • Other
  • At least 2 weeks since prior anticancer therapy or investigational agents
  • The following drugs must not be used for 1-2 weeks before, during, and for 1-2 weeks after completion of study treatment:
  • Ketoconazole
  • Itraconazole
  • Ritonavir
  • Mibefradil
  • Clarithromycin
  • Saquinavir mesylate
  • Indinavir sulfate
  • Erythromycin
  • Nefazodone hydrochloride
  • Fluconazole
  • Diltiazem hydrochloride
  • Alfentanil hydrochloride
  • Carbamazepine
  • Cyclosporine
  • Tacrolimus
  • Lovastatin
  • Simvastatin
  • Any other drug known to be a potent inhibitor of cytochrome 3A4
  • No other concurrent anticancer therapy or investigational agents

Exclusion

    Key Trial Info

    Start Date :

    April 26 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    January 6 2012

    Estimated Enrollment :

    34 Patients enrolled

    Trial Details

    Trial ID

    NCT00265876

    Start Date

    April 26 2006

    End Date

    January 6 2012

    Last Update

    August 4 2023

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, Canada, V5Z 4E6

    2

    Ottawa Health Research Institute - General Division

    Ottawa, Ontario, Canada, K1H 8L6

    3

    Algoma District Cancer Program

    Sault Ste. Marie, Ontario, Canada, P6B 0A8

    4

    Univ. Health Network-Princess Margaret Hospital

    Toronto, Ontario, Canada, M5G 2M9