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

NCT00265876 | Completed Phase 1 DMC

• 4 other identifiers: I173CAN-NCIC-IND173ZENECA-CAN-NCIC-IND173CDR0000450844
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 4

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 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.

Conditions

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas; stage III pancreatic cancer; recurrent pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (1)

• Response (complete [CR] and partial response [PR] or stable disease [SD]) at 8 weeks

  Response is assessed every other cycle and will be reported on at final analysis

  4 years

Secondary Outcomes (1)

• Toxicity

  4 years

Study Arms (1)

AZD0530 + Gemcitabine

EXPERIMENTAL

Drug: AZD0530; Drug: gemcitabine hydrochloride

Interventions

AZD0530 DRUG

Taken daily every 4 weeks

AZD0530 + Gemcitabine

gemcitabine hydrochloride DRUG

1000mg/m2 IV weekly

AZD0530 + Gemcitabine

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• NCIC Clinical Trials Group: lead
• AstraZeneca: collaborator

Study Sites (4)

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

Ottawa Health Research Institute - General Division

Ottawa, Ontario, K1H 8L6, Canada

Location

Algoma District Cancer Program

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

Location

Univ. Health Network-Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

• Renouf DJ, Moore MJ, Hedley D, Gill S, Jonker D, Chen E, Walde D, Goel R, Southwood B, Gauthier I, Walsh W, McIntosh L, Seymour L. A phase I/II study of the Src inhibitor saracatinib (AZD0530) in combination with gemcitabine in advanced pancreatic cancer. Invest New Drugs. 2012 Apr;30(2):779-86. doi: 10.1007/s10637-010-9611-3. Epub 2010 Dec 18.

  PMID: 21170669 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

saracatinib; 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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Malcolm J. Moore, MD

  Princess Margaret Hospital, Canada

  STUDY CHAIR

• Sharlene Gill, MD

  British Columbia Cancer Agency

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: December 14, 2005
• First Posted: December 15, 2005
• Study Start: April 26, 2006
• Primary Completion: January 8, 2009
• Study Completion: January 6, 2012
• Last Updated: August 4, 2023

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (4)