BIBF 1120 in Treating Patients With Recurrent or Persistent Endometrial Cancer

This study has suspended participant recruitment.
Sponsor:
Collaborators:
Boehringer Ingelheim
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01225887
First received: October 20, 2010
Last updated: May 28, 2013
Last verified: May 2013
  Purpose

RATIONALE: BIBF 1120 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying the side effects and how well BIBF 1120 works in treating patients with recurrent or persistent endometrial cancer.


Condition Intervention Phase
Endometrial Cancer
Drug: nintedanib
Phase 2

Study Type: Interventional
Study Design: Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Evaluation of BIBF 1120 (IND #) in the Treatment of Recurrent or Persistent Endometrial Carcinoma

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Primary Outcome Measures:
  • Progression-free survival for at least 6 months [ Designated as safety issue: No ]
  • Objective tumor response [ Designated as safety issue: No ]
  • Adverse events as assessed by NCI CTCAE v. 4.0 [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Progression-free survival and overall survival [ Designated as safety issue: No ]

Estimated Enrollment: 55
Study Start Date: October 2011
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • To estimate the proportion of patients with persistent or recurrent endometrial cancer, who survive progression-free without going on a subsequent therapy against the disease for at least 6 months
  • To assess objective tumor response (complete or partial) in patients with recurrent or persistent endometrial carcinoma treated with BIBF 1120.
  • To determine the nature and degree of toxicity of BIBI 1120 in these patients.

Secondary

  • To estimate the progression-free survival (PFS) and overall survival (OS) of patients with persistent or recurrent endometrial cancer treated with BIBF 1120.

OUTLINE: This is a multicenter study.

Patients receive oral BIBF 1120 twice daily on days 1-28. Courses repeat every 28 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed endometrial carcinoma (original primary tumor)

    • Recurrent or persistent disease that is refractory to curative therapy or established treatments
  • Patients with the following histologic epithelial cell types allowed:

    • Endometrioid adenocarcinoma
    • Serous adenocarcinoma
    • Undifferentiated carcinoma
    • Clear cell adenocarcinoma
    • Mixed epithelial carcinoma
    • Adenocarcinoma not otherwise specified (N.O.S.)
    • Mucinous adenocarcinoma
    • Squamous cell carcinoma
    • Transitional cell carcinoma
  • Measurable disease defined as ≥ 1 lesion that can be accurately measured in ≥ 1 dimension (longest to be recorded) as ≥ 10 mm by CT scan, MRI, or caliper measurement by clinical exam OR ≥ 20 mm by chest x-ray

    • Lymph nodes must be ≥ 15 mm in short axis by CT scan or MRI
  • Must have ≥ 1 "target lesion" to assess response on this protocol as defined by RECIST

    • 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 ≥ 90 days following completion of radiotherapy
  • Patients must not be eligible for a higher-priority GOG protocol, if one exists (e.g., any active GOG phase III protocol or rare tumor protocol for the same patient population)
  • Must have had 1 prior chemotherapy regimen for the management of endometrial carcinoma

    • Chemotherapy in conjunction with primary radiation as a radio-sensitizer is counted as a systemic chemotherapy regimen
  • No history or evidence of brain metastases or active CNS disease upon physical examination, including brain tumor

PATIENT CHARACTERISTICS:

  • GOG performance status 0-2
  • ANC ≥ 1,500/mm³
  • Platelet count ≥ 100,000/mm³
  • Creatinine ≤ 1.5 times upper limit of normal (ULN)
  • Urine protein creatinine (UPC) ratio < 1.0 g
  • Bilirubin ≤ 1.5 times ULN
  • AST and ALT ≤ 3.0 times ULN
  • Alkaline phosphatase ≤ 2.5 times ULN
  • INR ≤ 1.5 times ULN OR an in-range INR, usually between 2 and 3, if the patient is on a stable dose of therapeutic warfarin
  • PTT ≤ 1.5 times ULN
  • Normal thyroid function

    • History of hypothyroidism allowed provided it is well controlled with medication
  • EKG must have QTc < 450 msec without evidence of serious ventricular arrhythmia (ventricular tachycardia lasting more than 3 beats or ventricular fibrillation)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must agree to use effective contraception (two barrier methods of birth control) prior to, during, and for 3 months after final dose of BIBF 1120
  • No other invasive malignancies except non-melanoma skin cancer or curatively treated localized cancer of the breast, head and neck, or skin with no evidence of recurrent or metastatic disease for more than 3 years
  • No serious, non-healing wound, ulcer, or bone fracture, including the following:

    • History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 28 days
    • Underlying lesions that caused the fistula or perforation in the past that have not been corrected
  • No active bleeding or pathologic conditions that carry high-risk of bleeding, such as known bleeding disorder, coagulopathy, or tumor involving major vessels
  • No seizures not controlled with standard medical therapy
  • No clinically significant cardiovascular disease including, but not limited to, any of the following:

    • Uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg or diastolic BP > 90 mm Hg
    • Myocardial infarction or unstable angina within the past 6 months
    • NYHA class II-IV congestive heart failure
    • Women with an ejection fraction < normal
    • History of serious ventricular arrhythmia (i.e., ventricular tachycardia or ventricular fibrillation), or cardiac arrhythmias requiring anti-arrhythmic medications except atrial fibrillation that is well controlled with anti-arrhythmic medication
    • Peripheral vascular disease ≥ grade 2 by NCI CTCAE
    • History of cerebrovascular accident (CVA or stroke), transient ischemic attack (TIA), or subarachnoid hemorrhage within the past 6 months
  • No history of major thromboembolic event defined as symptomatic pulmonary embolism (PE), recurrent asymptomatic PE, or recurrent deep venous thrombosis
  • No prior thrombosis or thromboembolic event due to a known inherited coagulopathy (i.e., antithrombin-III deficiency, protein C or protein S deficiency, Factor V Leiden mutation presence, or prothrombin G20210A mutation)
  • No serious infections (except uncomplicated urinary tract infection) requiring systemic antibiotics or antiviral therapy, including known active hepatitis B or C infection, or HIV infection
  • No gastrointestinal or other medical disorder that would impact ingestion or absorption of the study drug
  • Patient must be able to swallow capsules
  • No history of photosensitivity
  • No significant traumatic injury within the past 28 days

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from recent surgery, radiotherapy, or chemotherapy
  • At least 1 week since prior hormonal therapy directed at the malignant tumor
  • At least 3 weeks since prior therapy directed to the malignant tumor, including chemotherapy and immunologic agents
  • One prior cytotoxic regimen for management of recurrent or persistent disease allowed
  • Patients must have NOT received any non-cytotoxic (biologic or targeted) agents, as part of their primary treatment or for management of recurrent or persistent disease

    • Non-cytotoxic (biologic or targeted) agents include (but are not limited to) monoclonal antibodies, cytokines, and small-molecule inhibitors of signal transduction
  • Prior hormonal therapy is allowed

    • There is no limit on the number of prior hormonal therapies allowed
  • No prior BIBF 1120
  • No prior cancer treatment that contraindicates this protocol therapy
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of endometrial cancer within the past 3 years

    • Any prior radiation therapy must be completed at least 4 weeks prior to registration
    • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed provided patient remains free of recurrence or metastatic disease
  • No prior chemotherapy for any abdominal cavity or pelvis other than for the treatment of endometrial cancer within the past 3 years

    • More than 3 years since prior adjuvant chemotherapy for localized breast cancer allowed provided patient remains free of recurrence or metastatic disease
  • No prior major surgical procedure or open biopsy within the past 28 days

    • No anticipation of these procedures during the course of the study
  • No minor surgical procedures, fine-needle aspirates, or core biopsies within the past 7 days
  • No agents that increase photosensitivity (e.g., topical retinoids and doxycycline) 1 week before, during, and 2 weeks after administration of BIBF 1120
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225887

  Hide Study Locations
Locations
United States, California
Providence Saint Joseph Medical Center
Burbank, California, United States, 91505
United States, Colorado
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
United States, Connecticut
Saint Francis Hospital and Medical Center
Hartford, Connecticut, United States, 06105
United States, Georgia
Memorial Health University Medical Center
Savannah, Georgia, United States, 31403
United States, Idaho
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States, 83706
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Evanston CCOP-NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
Sudarshan K Sharma MD Limted-Gynecologic Oncology
Hinsdale, Illinois, United States, 60521
United States, Indiana
Indiana University Medical Center
Indianapolis, Indiana, United States, 46202
Saint Vincent Oncology Center
Indianapolis, Indiana, United States, 46260
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Greater Baltimore Medical Center
Baltimore, Maryland, United States, 21204
United States, Michigan
Michigan Cancer Research Consortium Community Clinical Oncology Program
Ann Arbor, Michigan, United States, 48106
Saint Joseph Mercy Hospital
Ann Arbor, Michigan, United States, 48106-0995
Hurley Medical Center
Flint, Michigan, United States, 48502
Genesys Regional Medical Center
Grand Blanc, Michigan, United States, 48439
Allegiance Health
Jackson, Michigan, United States, 49201
Borgess Medical Center
Kalamazoo, Michigan, United States, 49001
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Saint Mary Mercy Hospital
Livonia, Michigan, United States, 48154
Saint Joseph Mercy Port Huron
Port Huron, Michigan, United States, 48060
United States, Mississippi
University of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Cox Medical Center
Springfield, Missouri, United States, 65807
Saint John's Hospital
Springfield, Missouri, United States, 65804
United States, Nebraska
Nebraska Methodist Hospital
Omaha, Nebraska, United States, 68114
United States, Nevada
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89169
United States, New York
Stony Brook University Medical Center
Stony Brook, New York, United States, 11794
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28203
Carolinas Medical Center - Northeast
Concord, North Carolina, United States, 28025
United States, Ohio
Akron General Medical Center
Akron, Ohio, United States, 44307
Case Western Reserve University
Cleveland, Ohio, United States, 44106
Cleveland Clinic Cancer Center/Fairview Hospital
Cleveland, Ohio, United States, 44111
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Hillcrest Hospital Cancer Center
Mayfield Heights, Ohio, United States, 44124
Lake University Ireland Cancer Center
Mentor, Ohio, United States, 44060
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
Cancer Care Associates-Yale
Tulsa, Oklahoma, United States, 74136-1929
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
Gynecologic Oncology Group
Philadelphia, Pennsylvania, United States, 19103
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
Lankenau Hospital
Wynnewood, Pennsylvania, United States, 19096
United States, Rhode Island
Women and Infants Hospital
Providence, Rhode Island, United States, 02905
United States, Texas
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Pacific Gynecology Specialists
Seattle, Washington, United States, 98104
Swedish Medical Center-First Hill
Seattle, Washington, United States, 98122-4307
Seattle Cancer Care Alliance
Seattle, Washington, United States, 98109-1023
Northwest Hospital
Seattle, Washington, United States, 98133
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology at Saint Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Holy Family Memorial Hospital
Manitowoc, Wisconsin, United States, 54221
Bay Area Medical Center
Marinette, Wisconsin, United States, 54143
Sponsors and Collaborators
Gynecologic Oncology Group
Boehringer Ingelheim
Investigators
Principal Investigator: Don S. Dizon, MD Women and Infants Hospital of Rhode Island
  More Information

Additional Information:
No publications provided

Responsible Party: Gynecologic Oncology Group
ClinicalTrials.gov Identifier: NCT01225887     History of Changes
Other Study ID Numbers: GOG-0229K, NCI-2011-02657
Study First Received: October 20, 2010
Last Updated: May 28, 2013
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Gynecologic Oncology Group:
endometrial adenocarcinoma
endometrial adenosquamous cell carcinoma
endometrial clear cell carcinoma
recurrent endometrial carcinoma

ClinicalTrials.gov processed this record on September 18, 2014