Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01168232
Other study ID # NCI-2011-02056
Secondary ID NCI-2011-02056GO
Status Completed
Phase Phase 2
First received
Last updated
Start date September 7, 2010
Est. completion date November 26, 2013

Study information

Verified date August 2019
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This phase II trial is studying the side effects and how well ixabepilone works in treating patients with persistent or recurrent uterine cancer. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop the growth of tumor cells, either by killing the cells of by stopping them from dividing.


Description:

PRIMARY OBJECTIVES:

I. To determine the response rate of ixabepilone in patients with persistent or recurrent carcinosarcoma of the uterus.

II. To determine the nature and degree of toxicity of ixabepilone in this cohort of patients.

SECONDARY OBJECTIVES:

I. To determine the duration of progression-free survival and overall survival.

TERTIARY OBJECTIVES:

I. To examine the expression of class III beta-tubulin in carcinosarcoma of the uterus.

II. To explore the association between class III beta-tubulin expression in carcinosarcoma of the uterus and response, progression-free and overall survival.

OUTLINE:

Patients receive ixabepilone IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed up every 3 months for 2 years and then every 6 months for 3 years.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date November 26, 2013
Est. primary completion date November 26, 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients must have histologically confirmed uterine carcinosarcoma which is persistent or recurrent with documented disease progression after appropriate local therapy; acceptable histologic type is defined as carcinosarcoma (malignant mixed muellerian tumor), homologous or heterologous type

- All patients must have measurable disease; measurable disease is defined by Response Evaluation Criteria In Solid Tumors (RECIST) (version 1.1); measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be >= 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or >= 20 mm when measured by chest x-ray; lymph nodes must be >= 15 mm in short axis when measured by CT or MRI

- Patients must have at least one ?target lesion? to be used to assess response on this protocol as defined by RECIST version 1.1; 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 not be eligible for a higher priority Gynecologic Oncology Group (GOG) protocol, if one exists; in general, this would refer to any active GOG Phase III or Rare Tumor protocol for the same patient population

- Patients must have a GOG Performance Status of 0, 1, or 2

- Recovery from effects of recent surgery, radiotherapy, or chemotherapy

- Patients should be free of active infection requiring antibiotics (with the exception of uncomplicated urinary tract infection [UTI])

- Any hormonal therapy directed at the malignant tumor must be discontinued at least one week prior to registration

- Any other prior therapy directed at the malignant tumor, including biological and immunologic agents, must be discontinued at least three weeks prior to registration

- Patients must have had one prior chemotherapeutic regimen for management of carcinosarcoma; initial treatment may include chemotherapy, chemotherapy and radiation therapy, and/or consolidation/maintenance therapy; chemotherapy administered in conjunction with primary radiation as a radio-sensitizer WILL be counted as a systemic chemotherapy regimen

- Patients who have NOT received prior therapy with a taxane (such as paclitaxel or docetaxel) MUST receive a second regimen that includes a taxane

- Patients must have NOT received any additional cytotoxic chemotherapy except as noted above

- Patients are allowed to receive, but are not required to receive, one additional non-cytotoxic regimen for management of recurrent or persistent disease according to the following definition:

- Non-cytotoxic (biologic or cytostatic) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction

- Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl

- Platelets greater than or equal to 100,000/mcl

- Creatinine less than or equal to 1.5 x institutional upper limit normal (ULN)

- Bilirubin less than or equal to 1.5 x ULN

- Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) less than or equal to 3 x ULN

- Alkaline phosphatase less than or equal to 2.5 x ULN

- Patients must have signed an approved informed consent and authorization permitting release of personal health information

Exclusion Criteria:

- Neuropathy (sensory and motor) less than or equal to grade 1

- Patients who have met the pre-entry requirements

- Patients of childbearing potential must have a negative serum pregnancy test 72 hours prior to the study entry and be practicing an effective form of contraception

- Patients who have received prior therapy with Ixabepilone

- Patients with a known history of severe (Common Terminology Criteria for Adverse Events [CTCAE] version [v]4.0) grade 3 or 4 hypersensitivity reaction to agents containing Cremophor? EL or its derivatives (eg, polyoxyethylated castor oil)

- Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, and other specific malignancies, are excluded if there is any evidence of other malignancy being present within the last three 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 three 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 who have received prior chemotherapy for any abdominal or pelvic tumor OTHER THAN for the treatment of uterine carcinosarcoma within the last three years are excluded; 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 are pregnant or nursing

Study Design


Intervention

Drug:
Ixabepilone
Given IV
Other:
Laboratory Biomarker Analysis
Correlative studies

Locations

Country Name City State
United States Abington Memorial Hospital Abington Pennsylvania
United States Summa Akron City Hospital/Cooper Cancer Center Akron Ohio
United States Michigan Cancer Research Consortium NCORP Ann Arbor Michigan
United States Saint Joseph Mercy Hospital Ann Arbor Michigan
United States University of Colorado Hospital Aurora Colorado
United States Sinai Hospital of Baltimore Baltimore Maryland
United States Saint Alphonsus Cancer Care Center-Boise Boise Idaho
United States State University of New York Downstate Medical Center Brooklyn New York
United States Cooper Hospital University Medical Center Camden New Jersey
United States Carolinas Medical Center/Levine Cancer Institute Charlotte North Carolina
United States Rush University Medical Center Chicago Illinois
United States University of Chicago Comprehensive Cancer Center Chicago Illinois
United States Case Western Reserve University Cleveland Ohio
United States Cleveland Clinic Cancer Center/Fairview Hospital Cleveland Ohio
United States Cleveland Clinic Foundation Cleveland Ohio
United States Medical Oncology and Hematology Associates-West Des Moines Clive Iowa
United States Mercy Cancer Center-West Lakes Clive Iowa
United States Riverside Methodist Hospital Columbus Ohio
United States John Muir Medical Center-Concord Campus Concord California
United States Beaumont Hospital-Dearborn Dearborn Michigan
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Saint John Hospital and Medical Center Detroit Michigan
United States Duke University Medical Center Durham North Carolina
United States Genesys Hurley Cancer Institute Flint Michigan
United States Genesys Regional Medical Center-West Flint Campus Flint Michigan
United States Hurley Medical Center Flint Michigan
United States Genesys Regional Medical Center Grand Blanc Michigan
United States Hartford Hospital Hartford Connecticut
United States Smilow Cancer Hospital Care Center at Saint Francis Hartford Connecticut
United States Sudarshan K Sharma MD Limted-Gynecologic Oncology Hinsdale Illinois
United States Indiana University/Melvin and Bren Simon Cancer Center Indianapolis Indiana
United States Saint Vincent Hospital and Health Care Center Indianapolis Indiana
United States University of Iowa/Holden Comprehensive Cancer Center Iowa City Iowa
United States Allegiance Health Jackson Michigan
United States University of Mississippi Medical Center Jackson Mississippi
United States Mercy Hospital Joplin Joplin Missouri
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States Gundersen Lutheran Medical Center La Crosse Wisconsin
United States Sparrow Hospital Lansing Michigan
United States Women's Cancer Center of Nevada Las Vegas Nevada
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States Saint Mary Mercy Hospital Livonia Michigan
United States University of Wisconsin Hospital and Clinics Madison Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States Lake University Ireland Cancer Center Mentor Ohio
United States Good Samaritan Regional Health Center Mount Vernon Illinois
United States The Hospital of Central Connecticut New Britain Connecticut
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Nebraska Methodist Hospital Omaha Nebraska
United States Florida Hospital Orlando Orlando Florida
United States Saint Joseph Mercy Oakland Pontiac Michigan
United States Lake Huron Medical Center Port Huron Michigan
United States Women and Infants Hospital Providence Rhode Island
United States Virginia Commonwealth University/Massey Cancer Center Richmond Virginia
United States Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri
United States Saint Mary's of Michigan Saginaw Michigan
United States Mercy Hospital Saint Louis Saint Louis Missouri
United States Saint Louis Cancer and Breast Institute-South City Saint Louis Missouri
United States Washington University School of Medicine Saint Louis Missouri
United States Memorial University Medical Center Savannah Georgia
United States Avera Cancer Institute Sioux Falls South Dakota
United States Cancer Research for the Ozarks NCORP Springfield Missouri
United States CoxHealth South Hospital Springfield Missouri
United States Mercy Hospital Springfield Springfield Missouri
United States Stony Brook University Medical Center Stony Brook New York
United States Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma
United States John Muir Medical Center-Walnut Creek Walnut Creek California
United States Saint John Macomb-Oakland Hospital Warren Michigan
United States Northwestern Medicine Cancer Center Warrenville Warrenville Illinois
United States Mercy Medical Center-West Lakes West Des Moines Iowa
United States Methodist West Hospital West Des Moines Iowa

Sponsors (2)

Lead Sponsor Collaborator
National Cancer Institute (NCI) NRG Oncology

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Objective Tumor Response Proportion of participants with objective tumor response. Objective tumor response is defined as complete or partial tumor response as assessed by RECIST 1.1. Every other cycle for first 6 months; then every 3 months thereafter until completion of study treatment; and at any other time if clinically indicated based on symptoms or physical signs suggestive of progressive disease.1 cycle is 21 days
Primary Adverse Events (Grade 3 or Higher) During Treatment Period. Number of participants with a maximum grade of 3 or higher during treatment period. Adverse events are graded and categorized using CTCAE v4.0 During treatment and up to 30 days after stopping the study treatment
Secondary Progression-free Survival Progression-free survival is the period of time from study entry to time of disease progression, death or date of last contact, whichever occurs first. Progression is assessed by RECIST 1.1 From study entry to disease progression, death or date of last contact, whichever occurs first, up to 5 years of follow-up.
Secondary Overall Survival Overall survival is defined as the duration of time from study entry to time of death or the date of last contact. From study entry to death or last contact, up to 5 years of follow-up.
See also
  Status Clinical Trial Phase
Completed NCT01010126 - Temsirolimus and Bevacizumab in Treating Patients With Advanced Endometrial, Ovarian, Liver, Carcinoid, or Islet Cell Cancer Phase 2
Completed NCT00390234 - Ziv-aflibercept in Treating Patients With Locally Advanced, Unresectable, or Metastatic Gynecologic Soft Tissue Sarcoma Phase 2
Completed NCT00245102 - Sorafenib in Treating Patients With Metastatic, Locally Advanced, or Recurrent Sarcoma Phase 2
Completed NCT00025506 - Thalidomide in Treating Patients With Recurrent or Persistent Carcinosarcoma of the Uterus Phase 2
Recruiting NCT05902988 - A Phase I/II Study of VLS-1488 in Subjects With Advanced Cancer Phase 1/Phase 2
Recruiting NCT05619913 - EPOCH: Eribulin and Pembrolizumab in Ovarian/Uterine Carcinosarcoma Phase 2
Completed NCT00687687 - 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 Phase 2
Completed NCT00114218 - Gemcitabine and Docetaxel in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Terminated NCT01367301 - Radiation Therapy, Paclitaxel, and Carboplatin in Treating Patients With Uterine Cancer N/A
Withdrawn NCT03902379 - Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer N/A
Completed NCT03694262 - The EndoBARR Trial (Endometrial Bevacizumab, Atezolizumab, Rucaparib) Phase 2
Completed NCT01247571 - Pazopanib Hydrochloride in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Terminated NCT01061606 - Temsirolimus in Treating Patients With Recurrent or Persistent Cancer of the Uterus Phase 2
Completed NCT00075400 - Imatinib Mesylate in Treating Patients With Recurrent or Persistent Uterine Cancer Phase 2
Completed NCT00659360 - AZD0530 in Treating Patients With Recurrent Locally Advanced or Metastatic Soft Tissue Sarcoma Phase 2
Completed NCT00238121 - Sorafenib in Treating Patients With Advanced or Recurrent Uterine Cancer Phase 2
Recruiting NCT05147558 - A Study of Pembrolizumab With Lenvatinib in Women With Advanced Uterine Carcinosarcoma Phase 2
Active, not recruiting NCT00954174 - Paclitaxel and Carboplatin or Ifosfamide in Treating Patients With Newly Diagnosed, Persistent or Recurrent Uterine, Ovarian, Fallopian Tube, or Peritoneal Cavity Cancer Phase 3
Completed NCT00478426 - Sunitinib Malate in Treating Patients With Recurrent or Metastatic Endometrial Cancer Phase 2
Active, not recruiting NCT05229601 - A Study of HFB301001 in Adult Patients With Advanced Solid Tumors Phase 1