Trial record 1 of 6 for:    GOG-0229K
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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

  Show 60 Study Locations
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 October 22, 2014