Ignite Creation Date:
2024-05-05 @ 11:38 PM
Last Modification Date:
2024-10-26 @ 10:37 AM
Study NCT ID:
NCT01379976
Status:
TERMINATED
Last Update Posted:
2015-04-24
First Post:
2011-06-16
Brief Title:
Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
Randomized Double-blind Placebo-controlled Phase 3 Trial to Assess the Efficacy and Safety of Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2014-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Recruitment was prematurely stopped due to difficulty of recruitment encountered by the experimental centers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Study objectives Primary To compare toxicity free survival of patients treated with ALC acetylcarnitine plus cisplatin-containing chemotherapy CHT versus those treated with placebo plus cisplatin-containing chemotherapy
Secondary To compare progression free survival overall survival the compliance to treatment the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events version 30 neurotoxicity as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events neuropathic pain intensity the clinical signs andor symptoms such as burning numbness itching etc of the sensorial neuropathy between the two treatment arms Study design Multicentre randomised double-blind placebo-controlled phase III superiority study in patients with advanced or metastatic NSCLC non small cell lung cancer
Patients to be screened for study inclusion are those for which the decision to start a cisplatin-containing treatment has been already taken in the context of the clinical practice The type of cisplatin-based treatment is not fixed but each single investigator is free to choose for each single patient among those already approved for first line treatment of advanced or metastatic NSCLC
Patients meeting the eligibility criteria will be randomized with a 1 1 ratio to receive ALC cisplatin-containing CHT or Placebo cisplatin-containing CHT until patient refusal disease progression unacceptable toxicity or death The study will be conducted in Italy in approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month period
Both efficacy and safety data will be collected Follow-up will be according to the clinical practice Data capture will continue for each patient until death or study closure
Secondary To compare progression free survival overall survival the compliance to treatment the number of episodes of grade 3-4 National Cancer Institute Common Terminology Criteria for Adverse Events version 30 neurotoxicity as well as the proportion of patients experiencing grade 2-3-4 National Cancer Institute Common Terminology Criteria for Adverse Events neuropathic pain intensity the clinical signs andor symptoms such as burning numbness itching etc of the sensorial neuropathy between the two treatment arms Study design Multicentre randomised double-blind placebo-controlled phase III superiority study in patients with advanced or metastatic NSCLC non small cell lung cancer
Patients to be screened for study inclusion are those for which the decision to start a cisplatin-containing treatment has been already taken in the context of the clinical practice The type of cisplatin-based treatment is not fixed but each single investigator is free to choose for each single patient among those already approved for first line treatment of advanced or metastatic NSCLC
Patients meeting the eligibility criteria will be randomized with a 1 1 ratio to receive ALC cisplatin-containing CHT or Placebo cisplatin-containing CHT until patient refusal disease progression unacceptable toxicity or death The study will be conducted in Italy in approximately 20 investigational centers in order to recruit 650-675 subjects over a 30-month period
Both efficacy and safety data will be collected Follow-up will be according to the clinical practice Data capture will continue for each patient until death or study closure
Detailed Description:
Inclusion criteria
Male or female 18
No previous CHT or targeted therapies Previous adjuvant or neo-adjuvant treatment is permitted if completed 6 months before study inclusion
ECOG performance status 0-1
Adequate organ functions defined as follows
Neutrophils 15 x 109L platelets 100 x 109L and hemoglobin 9 gdL
Bilirubin level either normal or 15 x ULN
ASAT and ALAT 25 x ULN 5 x ULN if liver metastasis are present
Serum creatinine 15 x ULN
Written informed consent given before the randomization according to International Conference on HarmonizationGood Clinical Practice ICHGCP
Exclusion criteria
Symptomatic brain metastases
Any investigational agents within 4 weeks prior to study entry
Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Patients with known allergy to any other components of the study drugs
History or presence of other disease metabolic dysfunction physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication
Known drug abuse alcohol abuse
Legal incapacity or limited legal capacity
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Clinically relevant peripheral neuropathy
Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial
Pregnancy or breast feeding Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
Presence of any psychological familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Male or female 18
No previous CHT or targeted therapies Previous adjuvant or neo-adjuvant treatment is permitted if completed 6 months before study inclusion
ECOG performance status 0-1
Adequate organ functions defined as follows
Neutrophils 15 x 109L platelets 100 x 109L and hemoglobin 9 gdL
Bilirubin level either normal or 15 x ULN
ASAT and ALAT 25 x ULN 5 x ULN if liver metastasis are present
Serum creatinine 15 x ULN
Written informed consent given before the randomization according to International Conference on HarmonizationGood Clinical Practice ICHGCP
Exclusion criteria
Symptomatic brain metastases
Any investigational agents within 4 weeks prior to study entry
Clinically relevant coronary artery disease or a history of a myocardial infarction within the last 12 months
Acute or sub-acute intestinal occlusion or history of inflammatory bowel disease
Patients with known allergy to any other components of the study drugs
History or presence of other disease metabolic dysfunction physical examination finding or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or patient at high risk from treatment complication
Known drug abuse alcohol abuse
Legal incapacity or limited legal capacity
Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or sign meaningful informed consent
Clinically relevant peripheral neuropathy
Any concurrent malignancy other than non-melanoma skin cancer or carcinoma in situ of the cervix Patients with a previous malignancy but without evidence of disease for 5 years will be allowed to enter the trial
Pregnancy or breast feeding Women of childbearing potential and their parents must be willing to practice acceptable methods of birth control to prevent pregnancy
Presence of any psychological familial sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None