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Ovarian CancerPhase 1NCT00672295

PH I SRC Kinase, Dasatinib Combo Paclitaxel & Carboplatin in Pts w Ovarian, Peritoneal, & Tubal Cancer

A Phase 1 study testing Dasatinib, Paclitaxel, and Carboplatin in people with Ovarian Cancer and Peritoneal Cancer, run by AA Secord at 2 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

Primary objective to determine the maximal tolerated (MTD) of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment. Secondary objectives to describe the toxicity of this combination of therapy; to describe the pharmacokinetics and pharmacodynamics parameters related to this… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Dasatinib, Paclitaxel, and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
2 sitesUnited States
Study dates
Aug 2007to Nov 2012
Phase
Phase 1
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

  • Pts must have histologic or cytologic evidence of ovarian, peritoneal, or tubal cancer
  • All pts must have measurable disease
  • > 18 yrs
  • Expected survival of at least 3 months
  • Pts must have GOG performance status pf 0, 1 or 2
  • Pts must have adequate:Bone marrow function, renal function, hepatic function, neurologic function
Show all 11Show fewer
  • No chemo, radiotherapy, biologic, hormonal, or investigational drug therapy within 28 days prior to study entry
  • Pts may have had up to 3 prior cytotoxic chemo regimens including prior treatment w carboplatin \& paclitaxel
  • Capable of providing written informed consent
  • Pts of childbearing potential must have negative serum pregnancy test prior to study entry \& be practicing effective method of birth control during course of study, in manner such that risk of failure is minimized. Prior to study enrollment, women of childbearing potential must be advised of importance of avoiding pregnancy during trial participation \& potential risk factors for unintentional pregnancy
  • Pts must have tissue block from their tumor available for evaluation for microarray \& immunoblot analyses. Pretreatment tumor tissue may be obtained from either archival tissue or be obtained by guided by guided core needle or simple biopsy it must be performed within four weeks prior to enrollment on study. Pts must have tumor that is accessible to biopsy \& consent to undergo post-treatment biopsy after cycle #2 of treatment as well

Who cannot join

  • Pts w epithelial ovarian tumors of low malignant potential (borderline tumor)
  • Pts w history of other invasive malignancies, w exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within last 5 yrs
  • Pts who have following cardiac conditions: uncontrolled angina or myocardial infarction within past 6 months; diagnosed or suspected congenital long QT syndrome; Any history of clinically significant ventricular arrhythmias; Prolonged QTc interval on pre-entry electrocardiogram on both Fridericia \& Bazett's correction; uncontrolled hypertension
  • History of significant bleeding disorder unrelated to cancer, including: diagnosed congenital bleeding disorders; diagnosed acquired bleeding disorder within 1 yr
  • Pts currently taking drugs that are generally accepted to have risk of causing Torsades de Pointes including: quinidine, procainamide, disopyramide; amiodarone, sotalol, ibutilide, dofetilide; erythromycins, clarithromycin; chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide; cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine
  • Serum creatinine > 1.5 times institutional upper limits of normal
Show all 10Show fewer
  • Pts taking certain concomitant medications, consider following prohibitions: medications that inhibit platelet function or anticoagulants
  • Pts who have received radiation therapy to > 30 percent of bone marrow
  • Pts w history of grade 3 hypersensitivity to paclitaxel or carboplatin
  • Pts w septicemia, severe infection, acute hepatitis, other uncontrolled severe medical conditions

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Duke University Health System

    Durham, North Carolina, 27701

  • Moffitt Cancer Center

    Tampa, Florida, 33612-9497

Other trials in United States

About this study

Official title: A Phase I Trial of A SRC Kinase Inhibitor, Dasatinib,in Combination With Paclitaxel and Carboplatin in Patients With Advanced or Recurrent Ovarian, Peritoneal, and Tubal Cancer

Primary objective to determine the maximal tolerated (MTD) of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment.

Secondary objectives to describe the toxicity of this combination of therapy; to describe the pharmacokinetics and pharmacodynamics parameters related to this combination; to describe the clinical activity as defined as the response rate (complete and partial response rate) and progression-free survival > 6 month; to compare the SRC pathway microarray signature in pre and post-treatment cancer specimens; to evaluate SRC pathway downstream substrates, FAX, paxcillin, and CRK-L in pre and post-treatment cancer specimens.

Read the detailed description

This is a phase I multicenter study designed to determine the maximal tolerated dose (MTD) and toxicity of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment in patients with advanced or recurrent ovarian, peritoneal, and tubal carcinoma. The MTD will be defined as the highest dose at which no more than 1 of 6 evaluable patient experiences a dose-limiting toxicity (DLT) due to the combination of dasatinib, paclitaxel,and carboplatin during the first cycle of treatment.

Being tested
Dasatinib, Paclitaxel, and Carboplatin
Keywords
Ovarian Cancer, Peritoneal Cancer, Tubal Cancer, Fallopian Tube Cancer, Dasatinib, Sprycel, Paclitaxel, Taxol, Carboplatin, Paraplatin
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

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

  • Dasatinib, Paclitaxel, and CarboplatinDrug

    Also called Dasatinib, Paclitaxel, Carboplatin, Taxol

    Dasatinib will be administered as an oral dose (tablet) as per the dose escalation (50 mg everyday - 250 mg everyday)continuously on days 2-21 in the first cycle (3 weeks) therapy and continuously (days 1-21) throughout the remainder of therapy.

    Paclitaxel will be administered on a 21-day schedule. Paclitaxel (150-175 mg/m^2) IV infused over 3 hours on day #1 of each cycle.

    Carboplatin (AUC=5-6 mg/,l/min) will be infused over 30-60 minutes every cycle via IV on day 1 of every cycle following the paclitaxel administration.

    All patients will be followed until disease progression or study withdrawal. In addition, following disease progression, patients will be monitored for delayed toxicity and survival for a period of 5 years and data entered into eDC, unless is withdrawn.

Study groups in NCT00672295
Study groupRoleWhat they receive
Dasatinib, paclitaxel,and carboplatinExperimentalCombination of dasatinib, paclitaxel,and carboplatin
Receives: Drug: Dasatinib, Paclitaxel, and Carboplatin

What is being measured

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

  1. To determine maximal tolerated dose (MTD) of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment

    Measured: 6 months

Secondary outcomes (5)

  1. To describe the toxicity of this combination of therapy

    Measured: 6 months

  2. To describe the pharmacokinetics and pharmacodynamics parameters related to this combination

    Measured: 6 months

  3. To describe the clinical activity as defined as the response rate (complete and partial response rate) and progression-free survival > 6 months

    Measured: 6 months

  4. To compare the SRC pathway microarray signature in pre and post-treatment cancer specimens

    Measured: 6 months

  5. To evaluate SRC pathway downstream substrates, FAX, paxcillin, and CRK-L in pre and post-treatment cancer specimens

    Measured: 6 months

Timeline

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

  1. First posted6 May 2008 (estimated)
  2. Study startAug 2007
  3. Primary completionSep 2011
  4. Study completionNov 2012

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00672295
Sponsor's protocol ID
Pro00012282
Other IDs
105821b, 9311-06-R0
Status last verified
Dec 2012
First submitted
4 May 2008
Last updated
28 Dec 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Secord AA, Teoh DK, Barry WT, Yu M, Broadwater G, Havrilesky LJ, Lee PS, Berchuck A, Lancaster J, Wenham RM. A phase I trial of dasatinib, an SRC-family kinase inhibitor, in combination with paclitaxel and carboplatin in patients with advanced or recurrent ovarian cancer. Clin Cancer Res. 2012 Oct 1;18(19):5489-98. doi: 10.1158/1078-0432.CCR-12-0507. Epub 2012 Jul 26.

    PubMed 22837181

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Dasatinib, Paclitaxel, and Carboplatin in people with Ovarian Cancer and Peritoneal Cancer, run by AA Secord at 2 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 11 inclusion and 10 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 28 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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 maximal tolerated dose (MTD) of dasatinib in combination with paclitaxel and carboplatin during the first cycle of treatment (time frame: 6 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 NCT00672295, 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 28 Dec 2012.

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