Comparative Study of Individualized Sensitivity-Directed Chemotherapy Versus DTIC

• Status: Unknown status
• Trial end date: 2013-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This phase III trial is aimed to investigate the efficacy of an individualized, sensitivity-directed combination chemotherapy in comparison to the standard regimen DTIC.

Two question are aimed to be answered by this study:

1. Is the individual chemosensitivity index (BICSI) a prognostic / predictive biomarker for chemotherapy ?

2. Is an individualized, sensitivity-directed combination chemotherapy superior to the standard regimen DTIC in terms of survival and response ?

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wuerzburg
• Collaborators: DCS Innovative Diagnostik Systeme; Hiege-Stiftung gegen Hautkrebs; medac GmbH
• Treatments: Cisplatin; Cytarabine; Dacarbazine; Paclitaxel; Treosulfan

Criteria

Inclusion Criteria:

• Histologically confirmed melanoma of the skin, mucosa, or unknown primary, diagnosed with surgically unresectable distant metastases (stage IV according to AJCC).

• At least one measurable target lesion according to RECIST, 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 metastatic 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

• Female patients should not be pregnant or nursing. Women of childbearing potential should be using a highly effective method of birth control (e.g. implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner). For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed.

• Male patients should use an effective method of contraception.

• 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.

Exclusion Criteria:

• All metastatic lesions are surgically resectable.

• Prior chemotherapy in stage IV (adjuvant chemotherapy in stage III allowed; one prior regimen of immunotherapy or targeted therapy in stage IV allowed).

• Primary melanoma of the uvea / choroidea.

• 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.

• ECOG/WHO performance index of 2 or higher

• 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.

• Any severe or uncontrolled hematological, renal or liver dysfunction as defined by the laboratory values given in Inclusion Criteria.

• Any clinically uncontrolled infectious disease including HIV positivity or AIDS-related illness.

• Any female patients who are pregnant or nursing.

• 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.