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

CompletedPhase 1, Phase 2

Sponsor: NCIC Clinical Trials Group

Conditions: Pancreatic Cancer

Interventions: AZD0530, gemcitabine hydrochloride

Countries: Canada

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 of tumor cells, either by killing the cells or by stopping them from dividing. Giving AZD0530 together with gemcitabine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of AZD0530 when given together with gemcitabine and to see how well they work in treating patients with locally advanced or metastatic pancreatic cancer that cannot be removed by surgery.

Eligibility overview

Sex: ALL

Age: 18 Years to 120 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (4)

Vancouver, British Columbia, Canada
Ottawa, Ontario, Canada
Sault Ste. Marie, Ontario, Canada
Toronto, Ontario, Canada