NCT00216112

Brief Summary

Imatinib mesylate is an inhibitor of the receptor tyrosine kinases for platelet-derived growth factor (PDGF) and stem cell factor (SCF), c-Kit, and inhibits PDGF- and SCF-mediated cellular events. Docetaxel promotes cell growth arrest by inhibiting the deassembly of tubulin and by promoting at the same time microtubule assembly. Docetaxel has single agent activity in ovarian cancer with response rates of 30-40% in the platinum refractory setting. The combination of imatinib mesylate and docetaxel has potential synergistic effects, based on previous reports showing synergy in-vitro and in-vivo between PDGFR inhibitors or PI3K inhibitors and taxane chemotherapy. This trial will investigate the efficacy the combination of imatinib mesylate and docetaxel in treating patients with advanced, platinum-refractory ovarian cancer and primary peritoneal carcinomatosis.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for phase_2 ovarian-cancer

Timeline
Completed

Started Dec 2003

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2003

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2005

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2007

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

September 12, 2005

Last Update Submit

February 17, 2016

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer

Outcome Measures

Primary Outcomes (1)

  • · To determine response rate (CR, PR and SD) of patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit receiving imatinib mesylate in combination with docetaxel.

    24 months

Secondary Outcomes (3)

  • · To assess the safety and tolerability of imatinib mesylate in combination with docetaxel in patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit.

    24 months

  • · To determine progression free survival and overall survival in patients with advanced, platinum-refractory ovarian cancer, whose tumors over-express PDGFR or c-kit, receiving imatinib mesylate in combination with docetaxel.

    24 months

  • · To determine whether basal level of Akt expression or Akt activation (phospho-Akt) in ovarian tumors impacts response to treatment with imatinib and docetaxel.

    24 months

Study Arms (1)

Investigational Treatment

EXPERIMENTAL

Imatinib Mesylate + Docetaxel

Drug: Imatinib MesylateDrug: Docetaxel

Interventions

Imatinib MesylateDRUG

Imatinib mesylate 600 mg po qd

Investigational Treatment
DocetaxelDRUG

Docetaxel 30 mg/m2 (4 of 6 weeks); 1 cycle = 6 weeks

Investigational Treatment

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically documented diagnosis of ovarian cancer, primary peritoneal carcinomatosis or fallopian tube cancer·
  • Immunohistochemical documentation of c-Kit or PDGFR expression by tumor
  • At least one measurable site of disease as defined by RECIST or evidence of disease progression by CA125 measurement
  • Platinum-refractory or platinum-resistant

You may not qualify if:

  • No prior exposure to imatinib (Gleevec®) as single agent or in combination
  • No chemotherapy within 28 days (42 days for nitrosourea or mitomycin-C) prior to being registered to protocol therapy.
  • No prior radiotherapy to ³ 25 % of the bone marrow
  • No known brain metastases.
  • Negative pregnancy test
  • No current breastfeeding
  • No investigational agents within 28 days prior to protocol therapy
  • No prior malignancy in the past 5 years unless the other primary malignancy is not currently clinically significant, nor requiring active intervention, or if other primary malignancy is a basal cell skin cancer or a cervical carcinoma in situ
  • No severe and/or uncontrolled medical disease (i.e., uncontrolled diabetes, chronic renal disease, or active uncontrolled infection)
  • No known diagnosis of human immunodeficiency virus (HIV) infection.
  • No major surgery within 28 days prior to being registered to protocol therapy.
  • No refractory ascites requiring drainage more frequently than once a month
  • No presence of clinically significant small bowel obstruction
  • No prior exposure to docetaxel (exposure to paclitaxel is allowed)
  • No parenteral nutrition within 28 days prior to being registered to protocol therapy.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Medical & Surgical Specialists, LLC

Galesburg, Illinois, 61401, United States

Location

Elkhart Clinic

Elkhart, Indiana, 46515, United States

Location

Oncology Hematology Associates of SW Indiana

Evansville, Indiana, 47714, United States

Location

Fort Wayne Oncology & Hematology, Inc

Fort Wayne, Indiana, 46815, United States

Location

Indiana University Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Arnett Cancer Care

Lafayette, Indiana, 47904, United States

Location

Medical Consultants, P.C.

Muncie, Indiana, 47303, United States

Location

Center for Cancer Care, Inc., P.C.

New Albany, Indiana, 47150, United States

Location

AP&S Clinic

Terre Haute, Indiana, 47804, United States

Location

Related Publications (1)

  • Matei D, Emerson RE, Schilder J, Menning N, Baldridge LA, Johnson CS, Breen T, McClean J, Stephens D, Whalen C, Sutton G. Imatinib mesylate in combination with docetaxel for the treatment of patients with advanced, platinum-resistant ovarian cancer and primary peritoneal carcinomatosis : a Hoosier Oncology Group trial. Cancer. 2008 Aug 15;113(4):723-32. doi: 10.1002/cncr.23605.

    PMID: 18618737RESULT

Related Links

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Imatinib MesylateDocetaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Intervention Hierarchy (Ancestors)

BenzamidesAmidesOrganic ChemicalsBenzoatesAcids, CarbocyclicCarboxylic AcidsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicDiterpenesTerpenes

Study Officials

  • Daniela Matei, M.D.

    Hoosier Oncology Group, LLC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Sponsor-Investigator

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 22, 2005

Study Start

December 1, 2003

Primary Completion

October 1, 2005

Study Completion

July 1, 2007

Last Updated

February 19, 2016

Record last verified: 2016-02

Data Sharing

IPD Sharing
Will not share

Locations

US(9)