Uterine CarcinosarcomaPhase 2NCT00687687
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 study testing paclitaxel, carboplatin and BSI-201 (Iniparib) in people with Uterine Carcinosarcoma, run by Sanofi at 40 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Uterine Carcinosarcoma
- What is being tested?
- paclitaxel, carboplatin and BSI-201 (Iniparib)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 40 sitesUnited States
- Study dates
- May 2008to Dec 2011
- 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
- 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
Who cannot join
- 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.
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
United States40 sites
Research Site
Abington, Pennsylvania
Research Site
Aurora, Colorado
Research Site
Baton Rouge, Louisiana, 70806
Research Site
Brooklyn, New York
Research Site
Buffalo, New York
Research Site
Burlington, Vermont, 05401
Research Site
Camden, New Jersey, 08103
Research Site
Chapel Hill, North Carolina
Research Site
Charlotte, North Carolina, 28204
Research Site
Charlotte, North Carolina
Research Site
Chicago, Illinois, 60612
Research Site
Chicago, Illinois
Research Site
Cleveland, Ohio
Research Site
Columbus, Ohio, 43235
Research Site
Columbus, Ohio
Research Site
Englewood, Colorado
Research Site
Gainsville, Georgia
Research Site
Hinsdale, Illinois
Research Site
Indianapolis, Indiana, 46260
Research Site
Kalamazoo, Michigan
Research Site
Madison, Wisconsin, 53792
Research Site
Mentor, Ohio
Research Site
New Britain, Connecticut
Research Site
New York, New York
Research Site
Oklahoma City, Oklahoma, 73104
Research Site
Orlando, Florida, 32804
Research Site
Pittsburgh, Pennsylvania
Research Site
Providence, Rhode Island, 02905
Research Site
Richmond, Virginia, 23298
Research Site
Roanoke, Virginia, 24014
Research Site
Savannah, Georgia
Research Site
Scarborough, Maine
Research Site
Springfield, Missouri, 65804
Research Site
St Louis, Missouri, 63110
Research Site
Stony Brook, New York
Research Site
Tulsa, Oklahoma
Research Site
Urbana, Illinois
Research Site
Winston-Salem, North Carolina, 27157
Research Site
Wynnewood, Pennsylvania
Research Site
Wyomissing, Pennsylvania
About this study
Official title: A Phase II 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
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.
- Conditions
- Uterine Carcinosarcoma
- Being tested
- paclitaxel, carboplatin, BSI-201 (Iniparib)
- Keywords
- Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxelDrug
Paclitaxel will be administered IV over 3 hours on Day 1 every 21 days.
carboplatinDrug
Carboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days.
BSI-201 (Iniparib)Drug
Also called SAR204550
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).
| Study group | Role | What they receive |
|---|---|---|
| Pacitaxel/Carboplatin/Iniparib | Experimental | 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. Receives: Drug: paclitaxel; Drug: carboplatin; Drug: BSI-201 (Iniparib) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2008 (estimated)
- Study startMay 2008
- Primary completionMar 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine CarcinosarcomaStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Responsible party
- Sponsor
- Investigators
- Clinical Sciences & Operations, Study director, Sanofi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00687687
- Sponsor's protocol ID
- TCD11615
- Other IDs
- GOG 0232C, 20070103
- Status last verified
- Aug 2012
- First submitted
- 28 May 2008
- Last updated
- 7 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
- Expanded access
- Available
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
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II 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
- ClinicalTrials.gov ID
- NCT00687687
- Acronym / sponsor ID
- TCD11615
- Conditions
- Uterine Carcinosarcoma
- Keywords
- Patients must have advanced (stage III or IV), persistent or recurrent uterine carcinosarcoma with documented disease progression.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Collaborators
- Gynecologic Oncology Group
- Study start
- May 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Jun 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pacitaxel/Carboplatin/Iniparib | Experimental | Drug: paclitaxel, Drug: carboplatin, Drug: BSI-201 (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paclitaxelPaclitaxel will be administered IV over 3 hours on Day 1 every 21 days. | Drug | Pacitaxel/Carboplatin/Iniparib |
| carboplatinCarboplatin will be administered intravenously (IV) over 30 minutes on day 1 after pacitaxel administration, every 21 days. | Drug | Pacitaxel/Carboplatin/Iniparib |
| BSI-201 (Iniparib)Also: SAR204550BSI-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). | Drug | Pacitaxel/Carboplatin/Iniparib |
Primary outcome
Clinical response rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2012.
- Derived from this study: PubMed 22634397Aghajanian 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Sciences & Operations study director
Sanofi
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paclitaxel, carboplatin and BSI-201 (Iniparib) in people with Uterine Carcinosarcoma, run by Sanofi at 40 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 5 inclusion and 7 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 7 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 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?
Clinical response rate (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 NCT00687687, 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 7 Aug 2012.