ClinicalTrials.gg
CompletedNCT00687687Updated Aug 7, 2012

Evaluation of Paclitaxel (Taxol, NSC #673089), Carboplatin (Paraplatin, NSC #241240), and BSI-201 (NSC #746045, IND #71,677) in the Treatment of Advanced, Persistent, or Recurrent Uterine Carcinosarcoma

A Phase 2 interventional study of paclitaxel and carboplatin in Uterine Carcinosarcoma, sponsored by Sanofi. Completed at 40 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-08-07.

Sponsored by Sanofi · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
22
Allocation
Not applicable
Ages
18 Years and older
Sex
Female
01

Study summary

To estimate the antitumor activity of paclitaxel, carboplatin, plus BSI-201 in patients with recurrent or advanced uterine carcinosarcomas.

Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.

02

Conditions studied

  • Uterine Carcinosarcoma

Keywords

  • Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
03

In context

Lead sponsor

Sanofi is the lead sponsor of 1,547 studies on the registry; 88 are open to participants now.

Of its 204 completed or terminated interventional studies of FDA-regulated products, 122 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression. Histologic confirmation of the original primary tumor is required.
  • All patients must have measurable disease. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each lesion must be greater than 20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or greater than 10 mm when measured by spiral CT.
  • Patients must have at least one "target lesion" to be used to assess response on this protocol as defined by RECIST (Section 8.1). Tumors within a previously irradiated field will be designated as "non-target" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.
  • Patients must have a GOG Performance Status of 0, 1, or 2.
  • Adequate bone marrow,renal, hepatic, and neurological function

Exclusion criteria

Exclusion Criteria:

  • Patients who have received prior cytotoxic chemotherapy for management of uterine carcinosarcoma.
  • Patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer and other specific malignancies as noted in Sections 3.23 and 3.24 are excluded if there is any evidence of other malignancy being present within the last five years. Patients are also excluded if their previous cancer treatment contraindicates this protocol therapy.
  • Patients who have received prior radiotherapy to any portion of the abdominal cavity or pelvis OTHER THAN for the treatment of uterine carcinosarcoma within the last five years are excluded. Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, provided that it was completed more than three years prior to registration, and the patient remains free of recurrent or metastatic disease.
  • Patients MAY have received prior adjuvant chemotherapy for localized breast cancer, provided that it was completed more than three years prior to registration, and that the patient remains free of recurrent or metastatic disease.
  • Patients who have symptomatic or untreated brain metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and corticosteroids.
  • Patients who have a significant history of cardiac disease, i.e., myocardial infarction (MI) within 6 months of study registration, unstable angina, congestive heart failure (CHF) with New York Heart Association (NYHA) > class II, or uncontrolled hypertension.
  • Patients who have a history of seizure disorder or are currently on anti-seizure medication.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
22 participants (actual)

Study arms

  • Experimental
    Pacitaxel/Carboplatin/Iniparib

    Participants will be administered pacitaxel, carboplatin and BSI-201 (Iniparib) in 21 day treatment cycles. Treatment will continue until disease progression or adverse effects prohibit further therapy.

    Drug: paclitaxel · Drug: carboplatin · Drug: BSI-201 (Iniparib)

Interventions

  • Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.

  • Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.

  • BSI-201 will be administered IV over one hour twice weekly beginning on day 1 (doses of BSI-201 must be separated by at least 2 days).

    Also known as: SAR204550

06

What researchers measure

Primary outcomes

  1. Clinical response rate

    Time frame: 6 months

07

Study locations

40 sites
  • Research Site
    Aurora, Colorado, United States
  • Research Site
    Englewood, Colorado, United States
  • Research Site
    New Britain, Connecticut, United States
  • Research Site
    Orlando, Florida 32804, United States
  • Research Site
    Gainsville, Georgia, United States
  • Research Site
    Savannah, Georgia, United States
  • Research Site
    Chicago, Illinois 60612, United States
  • Research Site
    Chicago, Illinois, United States
  • Research Site
    Hinsdale, Illinois, United States
  • Research Site
    Urbana, Illinois, United States
  • Research Site
    Indianapolis, Indiana 46260, United States
  • Research Site
    Baton Rouge, Louisiana 70806, United States
  • Research Site
    Scarborough, Maine, United States
  • Research Site
    Kalamazoo, Michigan, United States
  • Research Site
    Springfield, Missouri 65804, United States
  • Research Site
    St Louis, Missouri 63110, United States
  • Research Site
    Camden, New Jersey 08103, United States
  • Research Site
    Brooklyn, New York, United States
  • Research Site
    Buffalo, New York, United States
  • Research Site
    New York, New York, United States
  • Research Site
    Stony Brook, New York, United States
  • Research Site
    Chapel Hill, North Carolina, United States
  • Research Site
    Charlotte, North Carolina 28204, United States
  • Research Site
    Charlotte, North Carolina, United States
  • Research Site
    Winston-Salem, North Carolina 27157, United States
  • Research Site
    Cleveland, Ohio, United States
  • Research Site
    Columbus, Ohio 43235, United States
  • Research Site
    Columbus, Ohio, United States
  • Research Site
    Mentor, Ohio, United States
  • Research Site
    Oklahoma City, Oklahoma 73104, United States
  • Research Site
    Tulsa, Oklahoma, United States
  • Research Site
    Abington, Pennsylvania, United States
  • Research Site
    Pittsburgh, Pennsylvania, United States
  • Research Site
    Wynnewood, Pennsylvania, United States
  • Research Site
    Wyomissing, Pennsylvania, United States
  • Research Site
    Providence, Rhode Island 02905, United States
  • Research Site
    Burlington, Vermont 05401, United States
  • Research Site
    Richmond, Virginia 23298, United States
  • Research Site
    Roanoke, Virginia 24014, United States
  • Research Site
    Madison, Wisconsin 53792, United States
08

References and documents

Publications

  • Aghajanian C, Sill MW, Secord AA, Powell MA, Steinhoff M. Iniparib plus paclitaxel and carboplatin as initial treatment of advanced or recurrent uterine carcinosarcoma: a Gynecologic Oncology Group Study. Gynecol Oncol. 2012 Sep;126(3):424-7. doi: 10.1016/j.ygyno.2012.05.024. Epub 2012 May 24. PubMed 22634397 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of May 2008, a primary completion of Mar 2010 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 28, 2008
First posted
Jun 2, 2008
Start
May 2008
Primary completionActual
Mar 2010
CompletionActual
Dec 2011
Results delay requested
Jun 15, 2012
Last update
Aug 7, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 7, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00687687
Lead sponsor
Sanofi
Responsible party
Sponsor
First posted
Jun 2, 2008
Start date
May 2008
Primary completion
Mar 2010
Completion
Dec 2011
Last update
Aug 7, 2012

Study contacts

Clinical Sciences & Operations
study director · Sanofi

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Paclitaxel · Carboplatin · Iniparib

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