metastastic malignant melanoma (AJCC stage IV), not previously treated with chemotherapy (chemonaive) MedDRA version: 9.1 Level: LLT Classification code 10025650 Term: Malignant melanoma
Conditions
Interventions
Trade Name: DTIC (Detimedac) 100 mg
Product Name: dacarbazine (DTIC)
Pharmaceutical Form: Powder and solvent for solution for infusion
Trade Name: Cisplatin Lösung medac
Product Name: Cisplatin
Pharm
Sponsors
Universität Wuerzburg
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ¦ Histologically confirmed melanoma of the skin, mucosa, uvea/chorioidea or of unknown primary, diagnosed with surgically unresectable distant metastases (stage IV according to AJCC (Balch, Buzaid et al. 2001)). ¦ At least one measurable target lesion according to RECIST (Therasse, Arbuck et al. 2000), assessed by CT or MRI (tumor assessment by X-ray or ultrasonography only is not allowed). ¦ Access to a biopsy of ~1 cm3 from at least one metastastic lesion for in vitro chemosensitivity testing. Cell suspensions from malignant effusions are also eligible. ¦ No prior chemotherapy in stage IV (adjuvant chemotherapy in stage III allowed; one prior regimen of immunotherapy or targeted therapy in stage IV allowed). ¦ No evidence of brain/CNS metastases. Former history of brain/CNS metastases, which have been treated successfully, and are no longer visible in CT/MRI is allowed. ¦ Last complete tumor assessment (CT or MRI of thorax, abdomen and brain) not older than 14 days prior to registration, and not older than 5 weeks prior to onset of study treatment. ¦ ECOG/WHO performance index of 0 or 1. ¦ Patients must have stopped any kind of previous antineoplastic therapy for at least 2 weeks prior to registration, and at least 4 weeks prior to treatment onset. ¦ Patients must not have concurrent or recent malignancies except for surgically cured carcinoma in-situ of the cervix and basal or squamous cell carcinoma of the skin. Patients with previous malignancies, which have been treated with a subsequent disease-free interval of at least 5 years, are eligible. ¦ Patient age = 18 years. ¦ Adequate hematological, renal and liver function as defined by the following laboratory values performed within 14 days prior to randomisation: - absolute neutrophil count (ANC) = 1.5 x 109/l - platelet count = 100 x 109/l - hemoglobin = 9 g/dl - urea and serum creatinine = 2 times upper normal limit (UNL) - total and direct serum bilirubin = 2 times UNL - GOT or GPT = 2.5 times UNL; = 5 times UNL is allowed in case of liver metastasis - alkaline phosphatase =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - prior chemotherapy in stage IV - active brain metastases - ECOG/WHO performance index of 2 or higher. - hematological, renal and liver function not adequate as according to the laboratory values given in the inclusion criteria (e.g. severe renal or liver dysfunction) - female patients who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test simultaneously a) for prognostic value of BICSI, meaning that chemosensitive patients show significantly longer disease-specific overall survival than chemoresistant patients regardless of the administered therapy and b) for superiority of an individualized sensitivity-directed combination chemotherapy against DTIC monotherapy in the whole study population. ;Secondary Objective: a) To compare tumor response rate of the individualized sensitivity-directed combination chemotherapy and DTIC monochemotherapy. b) To compare toxicity of the individualized sensitivity-directed combination chemotherapy and DTIC monochemotherapy. c) To compare the progression-free survival of individualized sensitivity-directed combination chemotherapy and DTIC monochemotherapy. d) To evaluate descriptively differences between the two treatment groups in chemosensitive patients. ;Primary end point(s): The primary study endpoint is disease-specific overall survival (DSOS) measured from study inclusion until death from melanoma. | — |
Countries
Austria, Germany
Outcome results
None listed