Prospectively randomized phase III study of an individualized sensitivity-directed combination chemotherapy versus DTIC as first-line treatment in stage IV metastatic melanoma - ChemoSensMM

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 360

Inclusion Criteria

¦Histologically confirmed melanoma of the skin, mucosa, 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 < 2.5 times UNL

¦Patients should not suffer from any clinically uncontrolled infectious disease including HIV positivity or AIDS-related illness.

¦Female patients should not be pregnant or nursing. Women of childbearing potential should be using an effective method of contraception. Women of childbearing potential must have a negative pregnancy test 14 days prior to registration for the trial.

¦Male patients should use an effective method of contraception.

¦Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration for the trial.

¦Before registration, written informed consent must be given according to GCP guidelines and national/local regulations. Patients must be willing and giving informed consent to participation in the trial, including a tumor biopsy and peripheral blood withdrawal.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- prior chemotherapy in stage IV

- primary melanoma of the uvea / chorioidea

- 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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