Imatinib Mesylate and Gemcitabine in Treating Patients With Locally Advanced, Metastatic, or Recurrent Pancreatic Cancer

NCT00281996 | Terminated Phase 1 DMC

• 3 other identifiers: NU 02I8NU-02I8NU-0948-003
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Imatinib mesylate 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 imatinib mesylate together with gemcitabine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of giving imatinib mesylate together with gemcitabine and to see how well they work in treating patients with locally advanced, metastatic, or recurrent pancreatic cancer.

Conditions

Pancreatic Cancer

Keywords

recurrent pancreatic cancer; stage III pancreatic cancer; stage IV pancreatic cancer

Outcome Measures

Primary Outcomes (3)

• Determine maximum tolerated dose according to toxicity

  After 1 cycle of therapy (1 cycle = 21 days)

• Clinical response rate

  After every 2 cycles of study therapy (1 cycle = 21 days)

• Overall survival at 6 months

  After 6 months of study treatment

Interventions

Gemcitabine DRUG

Administered intravenously over 30 minutes on days 1 and 8 of a 21-day cycle starting at a dose of 700 mg/m2 and increasing to 1000mg/m2 by cohorts

Imatinib mesylate DRUG

Administered orally once daily with 8 ounces of water at a starting dose of 300 mg/day and increased to 600 mg/day according to cohort.

Also known as: Gleevec

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed pancreatic cancer * Locally advanced, metastatic, or recurrent disease * Measurable or evaluable disease by physical exam, plain radiographs, CT scan, or MRI * No brain metastases PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy of 12 weeks or greater * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 100,000/mm\^3 * Bilirubin ≤ 1.5 times upper limit of normal (ULN) * AST ≤ 2.5 times ULN (5 times ULN if liver metastases are present) * No chronic liver disease (i.e., chronic active hepatitis or cirrhosis) * Creatinine ≤ 2.0 mg/dL * No chronic renal disease * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective barrier-method contraception during and for ≥ 3 months after completion of study treatment * No other malignancy within the past 5 years except basal cell skin cancer or carcinoma in situ of the cervix * No uncontrolled diabetes * No active uncontrolled infection * No other severe and/or uncontrolled medical disease * HIV negative PRIOR CONCURRENT THERAPY: * No prior therapy for metastatic disease * Prior fluorouracil as a radiosensitizer for adjuvant therapy after surgery or for locally advanced disease is permitted if local disease has recurred or progressed ≥ 3 months after completion of therapy or disease is present outside the radiation field * At least 2 weeks since prior major surgery * No concurrent grapefruit or grapefruit juice

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

Sponsors & Collaborators

• Northwestern University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Chicago, Illinois, 60611, United States

Location

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

Study Officials

• Mary Mulcahy, MD

  Robert H. Lurie Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 24, 2006
• First Posted: January 25, 2006
• Study Start: March 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: August 26, 2011

Record last verified: 2011-08

Locations

US (1)