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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)

Phase 2
18 Years
Open (Enrolling)
Breast Cancer, Endometrial Cancer, Head and Neck Cancer, Melanoma (Skin), Ovarian Cancer, Sarcoma

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Trial Information

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)


- 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.

Inclusion Criteria


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

- 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

- 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


- 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

- 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


- 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

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Confirmed objective response rate (complete and partial responses) as defined by RECIST

Safety Issue:


Principal Investigator

Patrick Schoffski, MD, MPH

Investigator Role:

Study Chair

Investigator Affiliation:

U.Z. Gasthuisberg


United States: Federal Government

Study ID:




Start Date:

July 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • Endometrial Cancer
  • Head and Neck Cancer
  • Melanoma (Skin)
  • Ovarian Cancer
  • Sarcoma
  • recurrent squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • recurrent squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the oropharynx
  • recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
  • metastatic squamous neck cancer with occult primary squamous cell carcinoma
  • recurrent metastatic squamous neck cancer with occult primary
  • recurrent breast cancer
  • stage IV breast cancer
  • recurrent ovarian epithelial cancer
  • stage IV ovarian epithelial cancer
  • stage III ovarian epithelial cancer
  • recurrent adult soft tissue sarcoma
  • stage III adult soft tissue sarcoma
  • stage IV adult soft tissue sarcoma
  • adult leiomyosarcoma
  • uterine leiomyosarcoma
  • adult alveolar soft-part sarcoma
  • adult angiosarcoma
  • adult desmoplastic small round cell tumor
  • adult epithelioid sarcoma
  • adult fibrosarcoma
  • adult liposarcoma
  • adult malignant fibrous histiocytoma
  • adult malignant mesenchymoma
  • adult neurofibrosarcoma
  • adult rhabdomyosarcoma
  • adult synovial sarcoma
  • endometrial stromal sarcoma
  • ovarian carcinosarcoma
  • ovarian sarcoma
  • recurrent uterine sarcoma
  • stage IV uterine sarcoma
  • recurrent melanoma
  • stage IV melanoma
  • Breast Neoplasms
  • Endometrial Neoplasms
  • Head and Neck Neoplasms
  • Melanoma
  • Ovarian Neoplasms
  • Adenoma
  • Sarcoma