- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00526149
BI 2536 in Treating Patients With Recurrent or Metastatic Solid Tumors
Multicenter Parallel Phase II Trial of BI 2536 Administered as One Hour IV Infusion Every 3 Weeks in Defined Cohorts of Patients With Various Solid Tumors. A New Drug Screening Program of the EORTC Network of Core Institutions (NOCI)
RATIONALE: BI 2536 may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying the side effects and how well BI 2536 works in treating patients with recurrent or metastatic solid tumors.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
OBJECTIVES:
- Investigate if BI 2536 demonstrates antitumor activity in the selected tumor types.
- Further document its safety profile in the treated patient population.
- Describe the plasma concentration time-course following administration of a single administration of BI 2536 in patients with different tumor types using an appropriate population pharmacokinetic model.
OUTLINE: This is a multicenter study.
Patients receive BI 2536 IV over 1 hour on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Blood is collected periodically during study. Plasma samples are analyzed for pharmacokinetic studies by HPLC and tandem mass spectrometry.
After completion of study treatment, patients are followed every 3 months.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Leuven, Belgium, B-3000
- U.Z. Gasthuisberg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
DISEASE CHARACTERISTICS:
Tumor-specific criteria:
Head and neck cancer:
- Histologically or cytologically proven squamous cell carcinoma of the head and neck (excluding nasopharyngeal primaries)
- Patients presenting with new non-irradiated lesions in pre-irradiated field as target lesions are eligible
- Recurrent or metastatic disease, no longer suitable for local therapy
- Prior use of chemotherapy/chemoradiotherapy/EGFR inhibitors for the treatment of the primary disease/nonmetastatic disease is allowed
No prior chemotherapy for recurrent or metastatic disease
- Prior treatment with EGFR inhibitor for metastatic advanced disease is allowed
Breast cancer
- Histologically proven recurrent or metastatic adenocarcinoma of the breast that failed prior taxane and anthracycline therapy
- Patient must have had a minimum of one line and a maximum of 2 lines of chemotherapy treatment given either as adjuvant treatment or for recurrence/metastatic disease
- Patients who do not qualify for Her-2-based therapy allowed
- Hormone receptor status not specified
Ovarian cancer
- Histologically proven ovarian epithelial cancer
- Metastatic or inoperable locally advanced disease
- Patients either progressing under or relapsing within 6 months of completion of any line of platinum and taxane-based therapeutic regimen for advanced disease
Soft tissue sarcoma
Histologically proven advanced and/or metastatic malignant soft tissue sarcoma of high or intermediate grade and one of the following histologies defined by the WHO classification 2002:
- Leiomyosarcoma, adipocytic sarcoma, synovial sarcoma, and others
- Fibroblastic (adult fibrosarcoma, myxofibrosarcoma, sclerosing epithelioid fibrosarcoma)
- So-called fibrohistiocytic (pleomorphic malignant fibrous histiocytoma [MFH], giant cell "MFH", inflammatory "MFH")
- Malignant glomus tumors
- Skeletal muscles (rhabdomyosarcoma, alveolar or pleomorphic) excluding embryonic rhabdomyosarcoma
- Vascular (epithelioid hemangioendothelioma, angiosarcoma)
- Uncertain differentiation (synovial, epithelioid, alveolar soft part, clear cell, desmoplastic small round cell, extra-renal rhabdoid, malignant mesenchymoma, perivascular epithelioid cell tumour [PEComa], intimal sarcoma) excluding chondrosarcoma, Ewing tumors/primitive neuroectodermal tumor (PNET)
- Malignant peripheral nerve sheath tumors
- Malignant solitary fibrous tumors
- Undifferentiated soft tissue sarcomas not otherwise specified
- Other types of sarcoma (not listed as not eligible), if approved by the Study Coordinator (written or e-mail approval needed prior to registration)
Excluded are any of the following:
- Embryonic rhabdomyosarcoma
- Chondrosarcoma
- Osteosarcoma
- Ewing tumors/primitive neuroectodermal tumors
- Gastrointestinal stromal tumor
- Dermatofibrosarcoma protuberans
- Inflammatory myofibroblastic sarcoma
- Neuroblastoma
- Malignant mesothelioma
- Mixed mesodermal tumors of the uterus
- Patients must have received no more than one combination or two single agents of chemotherapy regimen for advanced disease and treatment must have included an anthracycline if not medically contraindicated
Melanoma
- Histologically proven metastatic malignant melanoma
- Ocular melanomas are excluded
Patients must either not have received any prior chemotherapy for recurrent /metastatic disease or have received one line of chemotherapy pending LDH ≤ 2 times upper limit of normal (ULN)
- One prior line of immunotherapy is allowed
General criteria:
- Measurable disease, defined as unidimensionally measurable based on RECIST with a target lesion of at least 20 mm or 10 mm measured by spiral CT scan
- Documented progressive disease proven by imaging prior to study entry (i.e., progression should be documented by 2 imaging scans performed within the past 6 months prior to registration showing progression according to RECIST)
- No clinical evidence of brain metastases
PATIENT CHARACTERISTICS:
- Male or female
- Menopausal status not specified
- ECOG performance status 0-2
- ANC ≥ 1.5 x 10^9/L
- Platelets ≥ 100 x 10^9/L
- Hemoglobin ≥ 9 mg/dL
- Serum creatinine ≤ to 175 μmol/L
- Bilirubin ≤ 1.5 times ULN
- AST/ALT ≤ 2.5 times ULN (5 times ULN with liver metastases)
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 12 months after completion of study treatment
- Absence of any psychological, familial, sociological, or geographical factors that would potentially hamper compliance with the study protocol and follow-up schedule
- No other previous or active malignancy for at least 5 years with the exception of cone-biopsied carcinoma of the cervix and adequately treated basal or squamous cell skin carcinoma
No concomitant intercurrent illnesses including, but not limited to, any of the following:
- Ongoing or active infection
- Symptomatic congestive heart failure
- Unstable angina pectoris
- Cardiac arrhythmia
- Psychiatric illness or social situation that would limit compliance with trial requirement or that are considered relevant for the evaluation of the efficacy or safety of the trial drug
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- At least 4 weeks since administration of any prior systemic treatment for the current malignancy including treatment with chemotherapy, radiotherapy, immunotherapy, hormonal therapy, and treatment with monoclonal antibodies, or small molecule tyrosine kinase inhibitors and others
- No persistence of toxicities from prior anticancer therapy deemed clinically relevant
- No treatment with any other investigational drug within the past four weeks or within less than four half-life times of the investigational drug before treatment with the trial drug (whatever is the longest period)
- No major surgery within 4 weeks prior to the first treatment with the trial drug
- Concurrent treatment with corticosteroids, including prednisone and bisphosphonates, is allowed as long as the treatment started before entry into the study and as long as the dose is stable for two weeks prior to enrollment in the present trial
Palliative radiotherapy may be given during the study for bone pain or for other reasons not due to progressive disease (e.g., bronchial obstruction, ulcerating skin lesions)
- The irradiated area should be limited and should not involve more than 10% of the bone marrow
- The irradiated area cannot be used for tumor response assessment
- No other concurrent investigational drugs
- No concurrent anti-tumor therapies such as chemotherapy, hormone therapy, gene therapy, tyrosine kinase inhibitors, or therapy with monoclonal antibodies or immunotherapy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Confirmed objective response rate (complete and partial responses) as defined by RECIST
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Secondary Outcome Measures
Outcome Measure |
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Overall survival
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Duration of response
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Clinical benefit as assessed by RECIST
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Overall progression-free survival
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Safety as assessed by CTCAE version 3.0
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Collaborators and Investigators
Investigators
- Study Chair: Patrick Schoffski, MD, MPH, University Hospital, Gasthuisberg
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- stage IV breast cancer
- recurrent breast cancer
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- recurrent ovarian epithelial cancer
- recurrent melanoma
- stage IV melanoma
- adult angiosarcoma
- adult fibrosarcoma
- adult leiomyosarcoma
- adult liposarcoma
- adult neurofibrosarcoma
- adult synovial sarcoma
- stage IV adult soft tissue sarcoma
- recurrent adult soft tissue sarcoma
- adult alveolar soft-part sarcoma
- adult epithelioid sarcoma
- adult malignant fibrous histiocytoma
- adult malignant mesenchymoma
- adult rhabdomyosarcoma
- stage IV uterine sarcoma
- recurrent uterine sarcoma
- uterine leiomyosarcoma
- endometrial stromal sarcoma
- ovarian sarcoma
- stage III adult soft tissue sarcoma
- adult desmoplastic small round cell tumor
- ovarian carcinosarcoma
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Uterine Neoplasms
- Genital Neoplasms, Female
- Uterine Diseases
- Breast Diseases
- Neuroectodermal Tumors
- Neoplasms, Germ Cell and Embryonal
- Neoplasms, Nerve Tissue
- Neuroendocrine Tumors
- Nevi and Melanomas
- Sarcoma
- Breast Neoplasms
- Head and Neck Neoplasms
- Endometrial Neoplasms
- Melanoma
Other Study ID Numbers
- EORTC-90061
- EUDRACT-2006-004529-27
- EORTC-90061-BI 1216.18
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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