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)
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.
OBJECTIVES:
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.
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
Breast cancer
Ovarian cancer
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:
Excluded are any of the following:
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)
General criteria:
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:
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)
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