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Ovarian CancerPhase 2NCT00216112

Imatinib Mesylate in Combination With Docetaxel for Advanced, Platinum-Refractory Ovarian Cancer

A Phase 2 study testing Imatinib Mesylate and Docetaxel in people with Ovarian Cancer, run by Daniela Matei, MD at 9 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Imatinib Mesylate and Docetaxel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
9 sitesUnited States
Study dates
Dec 2003to Jul 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 21Show fewer
  • 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.
  • No concomitant treatment with potent CYP 3A4 inhibitors (i.e., ketoconazole) is permitted during therapy on this protocol.
  • No therapeutic anticoagulation with warfarin while on study (use of low molecular weight heparin is allowed, if necessary).
  • No peripheral neuropathy > grade 1
  • No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80.
  • No serious concomitant systemic disorders incompatible with the study
  • No prior malignancies with the exception of curatively treated basal or squamous carcinoma of the skin, carcinoma in-situ of the cervix, or any other cancer for which the patient has been disease-free for < 5 years.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Elkhart Clinic

    Elkhart, Indiana, 46515

  • Oncology Hematology Associates of SW Indiana

    Evansville, Indiana, 47714

  • Fort Wayne Oncology & Hematology, Inc

    Fort Wayne, Indiana, 46815

  • Medical & Surgical Specialists, LLC

    Galesburg, Illinois, 61401

  • Indiana University Cancer Center

    Indianapolis, Indiana, 46202

  • Arnett Cancer Care

    Lafayette, Indiana, 47904

  • Medical Consultants, P.C.

    Muncie, Indiana, 47303

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

    New Albany, Indiana, 47150

  • AP&S Clinic

    Terre Haute, Indiana, 47804

Other trials in United States

About this study

Official title: Imatinib Mesylate (Gleevec®, STI571) in Combination With Docetaxel (Taxotere) for the Treatment of Advanced, Platinum-Refractory Ovarian Cancer and Primary Peritoneal Carcinomatosis: Hoosier Oncology Group GYN03-62

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.

Read the detailed description

OUTLINE: This is a multi-center study.

Submit tumor and serum samples for central review

  • Imatinib 600 mg (orally qd);
  • Docetaxel 30mg/m2 (4 of 6 weeks);1 cycle = 6 weeks
  • Evaluate every other cycle

Each cycle will begin only when the granulocyte count is > 1,500/mm3 and the platelet count is > 100,000/mm3 and any other treatment-related toxicities are < grade 1. If the toxicity is not resolved to grade 0 or 1 after three weeks, the patient will be withdrawn from the study. For days 8, 15, and 22 patients must have an absolute neutrophil count > 1,000/mm3 or greater and platelet count > 75,000/mm3. Imatinib mesylate can be administered if platelets >20,000 and ANC >500.

ECOG performance status 0 or 1

Hematopoietic:·

  • ANC > 1,500/mm3·
  • Platelets > 100,000 mm3·
  • Hgb > 8g/dl

Hepatic:·

  • Albumin>3gm/dL·
  • Total bilirubin < ULN·
  • Maximum Alk Phos: >2.5x but < 5x ULN

Renal:·

  • Creatinine < 1.5 x ULN·(by Cockroft and Gault)

Cardiovascular:·

  • No grade III/IV cardiac problems as defined by the New York Heart Association Criteria. (i.e., congestive heart failure, myocardial infarction within 6 months prior to beginning protocol therapy)

Pulmonary:·

  • Not specified
Conditions
Ovarian Cancer
Being tested
Imatinib Mesylate, Docetaxel
Keywords
Ovarian Cancer
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Imatinib MesylateDrug

    Imatinib mesylate 600 mg po qd

  • DocetaxelDrug

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

Study groups in NCT00216112
Study groupRoleWhat they receive
Investigational TreatmentExperimentalImatinib Mesylate + Docetaxel
Receives: Drug: Imatinib Mesylate; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 24 months

Secondary outcomes (3)

  1. · 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.

    Measured: 24 months

  2. · 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.

    Measured: 24 months

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

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Sep 2005 (estimated)
  2. Study startDec 2003
  3. Primary completionOct 2005
  4. Study completionJul 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00216112
Sponsor's protocol ID
HOG GYN 03-62
Status last verified
Feb 2016
First submitted
12 Sep 2005
Last updated
19 Feb 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 18618737

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Imatinib Mesylate and Docetaxel in people with Ovarian Cancer, run by Daniela Matei, MD at 9 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

· 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. (time frame: 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00216112, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2016.

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