Gemcitabine and Imatinib Mesylate as First-Line Therapy in Patients With Locally Adv. or Metastatic Pancreatic Cancer

NCT00161213 | Completed Phase 2 Results DMC

• 5 other identifiers: CDR0000539409P30CA072720CINJ-070501CINJ-5324CINJ-NJ1205
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 8

Brief Summary

RATIONALE: 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. Imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving gemcitabine together with imatinib mesylate may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving gemcitabine together with imatinib mesylate works as first-line therapy in treating patients with locally advanced or metastatic pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Progression-free Survival

  Progression-free survival in months. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions

  4 years

Secondary Outcomes (3)

• Response Rate

  5 years

• 1-year Survival Rate

  5 years

• Overall Survival

  5 years

Study Arms (1)

Gemcitabine and Imatinib

EXPERIMENTAL

Drug: gemcitabine hydrochloride; Drug: imatinib mesylate

Interventions

gemcitabine hydrochloride DRUG

Gemcitabine and Imatinib

imatinib mesylate DRUG

Gemcitabine and Imatinib

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 or poorly differentiated carcinoma (originating in the pancreas) * Locally advanced or metastatic disease * Not eligible for curative resection * Must have measurable or evaluable disease as defined by RECIST criteria * No CA19-9 elevation as only evidence of disease * No known brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Absolute neutrophil count ≥ 1,500/mm³ * Platelet count ≥ 125,000/mm³ * Bilirubin \< 1.5 times upper limit of normal (ULN) * AST and ALT ≤ 2.5 times ULN * Alkaline phosphatase \< 3 times ULN * Creatinine ≤ 1.5 times ULN OR creatinine clearance ≥ 60 mL/min * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective nonhormonal contraception * No coexisting medical condition that would preclude study compliance * No inability to ingest tablets * No active illness (e.g., active or uncontrolled infection, uncontrolled cardiac disease) that would preclude study participation * No chronic uncontrolled diarrhea and/or daily emesis * No other cancer within the past 5 years except for surgically removed noninvasive nonmelanoma skin cancer or in situ cervical cancer PRIOR CONCURRENT THERAPY: * No prior chemotherapy for metastatic disease * No prior gemcitabine * No prior imatinib mesylate * Prior surgical resection and adjuvant fluorouracil chemotherapy allowed provided there was an interval of \> 6 months between the last dose of adjuvant chemotherapy and recurrence of pancreatic cancer * Prior fluorouracil as a radiosensitizing agent allowed * At least 4 weeks since prior radiotherapy and recovered * Must have evidence of disease outside the radiation fields OR radiologically confirmed disease progression within the radiation fields after completion of radiotherapy * No concurrent therapeutic warfarin * Prophylactic warfarin ≤ 1 mg daily allowed for prophylaxis of central venous catheter thrombosis * Low molecular weight heparin or heparin allowed for anticoagulation * No concurrent chronic systemic corticosteroids * No other concurrent agents or therapies, including chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, or cancer surgery * No other concurrent experimental medications * No concurrent filgrastim (G-CSF) or sargramostim (GM-CSF)

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

Sponsors & Collaborators

• University of Medicine and Dentistry of New Jersey: lead
• National Cancer Institute (NCI): collaborator

Study Sites (8)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611-3013, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Cancer Institute of New Jersey at Hamilton

Hamilton, New Jersey, 08690, United States

Location

Jersey Shore Cancer Center at Jersey Shore University Medical Center

Neptune City, New Jersey, 07754, United States

Location

Central Jersey Oncology Group

New Brunswick, New Jersey, 08901, United States

Location

Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903, United States

Location

Saint Peter's University Hospital

New Brunswick, New Jersey, 08903, United States

Location

New Jersey Medical School

Newark, New Jersey, 07103, United States

Location

Related Publications (1)

• Moss RA, Moore D, Mulcahy MF, Nahum K, Saraiya B, Eddy S, Kleber M, Poplin EA. A Multi-institutional Phase 2 Study of Imatinib Mesylate and Gemcitabine for First-Line Treatment of Advanced Pancreatic Cancer. Gastrointest Cancer Res. 2012 May;5(3):77-83.

  PMID: 22888387 RESULT

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

Gemcitabine; Imatinib Mesylate

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; Benzamides; Amides; Organic Chemicals; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Piperazines

Results Point of Contact

• Title: Dr. Susan Goodin (Deputy Director, Associate Director for Clinical Science)
• Organization: UMDNJ

goodin@umdnj.edu

732-235-6783

Study Officials

• Elizabeth A. Poplin, MD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 1, 2005
• Primary Completion: October 1, 2010
• Study Completion: October 1, 2010
• Last Updated: August 14, 2023
• Results First Posted: December 27, 2012

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)