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Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer

Primary Purpose

Non Small Cell Lung Cancer

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

Acetylcarnitine

Placebo

About this trial

This is an interventional treatment trial for Non Small Cell Lung Cancer focused on measuring lung, cancer, non small cell lung cancer, Advanced or metastatic non small cell lung cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL
Bilirubin level either normal or < 1.5 x ULN
ASAT and ALAT < 2.5 x ULN (< 5 x ULN if liver metastasis are present)
Serum creatinine <1.5 x ULN
Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP)

Exclusion Criteria:

Symptomatic brain metastases
Any investigational agent(s) 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

Sites / Locations

Istituto Oncologico del Mediterraneo
Azienda Ospedaliera Ospedale S. Anna
Azienda Ospedaliera Istituti Ospitalieri
Azienda Ospedaliera di Desio e Vimercate - Presidio Ospedaliero di Desio
Ospedale Civile
Ospedale Alessandro Manzoni
Azienda Ospedaliera Ospedale Civile di Legnano
Azienda Ospedaliera Fatebenefratelli e Oftalmico
Istituto Europeo Di Oncologia
Azienda Ospedaliera San Paolo
Azienda Ospedaliera Ospedale San Carlo Borromeo
Azienda Ospedaliero Universitaria di Parma
Fondazione Salvatore Maugeri
Azienda Ospedaliera Perugia
Arcispedale S. Maria Nuova
IRCCS di Reggio Emilia
Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero di Saronno
Ospedale SS Annunziata - ASL1
Azienda Ospedaliera Valtellina e Valchiavenna , Presidio Ospedaliero di Sondrio
Azienda Ospedaliera di Pavia, Ospedale Civile di Vigevano
Azienda Ospedaliera di Desio e Vimercate - Presidio Ospedaliero di Vimercate

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

CHT cisplatin containing + placebo

CHT cisplatin containing + acetyl-L-carnitina

Arm Description

Outcomes

Primary Outcome Measures

Toxicity Free Survival

The primary efficacy endpoint is toxicity-free survival, defined as the time from randomisation up to the occurrence of related to treatment grade 2-3-4 NCI-CTCAE neurotoxicity, progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not experienced related to treatment grade 2-3-4 toxicity, and not progressed or died while on study will be censored at their last assessment date.

Secondary Outcome Measures

Progression-free survival

defined as the time from randomisation up to the occurrence of progression, second primary malignancy, death from any cause, whichever comes first. Subjects who have not progressed or died while on study will be censored at their last assessment date

Overall survival

defined as the time from the date of randomisation to the date of death from any cause. Subjects not reported as having died at the end of the study will be censored at the date they were last known to be alive

Neuropathic pain

Occurrence of neuropathic pain is defined as the presence of at least 4 of the 10 clinical signs/symptoms listed in the DN4-Questionnaire Neuropathic pain intensity is defined as the intensity of pain reported by patients (current, average and worst during the last week) during scheduled visit as assessed by a self-administered questionnaire (BPI)

Full Information

NCT ID

NCT01379976

First Posted

June 16, 2011

Last Updated

April 23, 2015

Sponsor

Mario Negri Institute for Pharmacological Research

1. Study Identification

Unique Protocol Identification Number

NCT01379976

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Terminated

Why Stopped

Recruitment was prematurely stopped due to difficulty of recruitment encountered by the experimental centers

Study Start Date

April 2011 (undefined)

Primary Completion Date

October 2014 (Actual)

Study Completion Date

October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mario Negri Institute for Pharmacological Research

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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 3.0, 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 and/or 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 >= 1.5 x 109/L, platelets >= 100 x 109/L, and hemoglobin >= 9 g/dL Bilirubin level either normal or < 1.5 x ULN ASAT and ALAT <= 2.5 x ULN (<= 5 x ULN if liver metastasis are present) Serum creatinine <1.5 x ULN Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP) Exclusion criteria: Symptomatic brain metastases Any investigational agent(s) 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Non Small Cell Lung Cancer

Keywords

lung, cancer, non small cell lung cancer, Advanced or metastatic non small cell lung cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

107 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CHT cisplatin containing + placebo

Arm Type

Placebo Comparator

Arm Title

CHT cisplatin containing + acetyl-L-carnitina

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Acetylcarnitine

Other Intervention Name(s)

ST 200

Intervention Description

ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals). Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Primary Outcome Measure Information:

Title

Toxicity Free Survival

Description

Time Frame

participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months

Secondary Outcome Measure Information:

Title

Progression-free survival

Description

Time Frame

participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months

Title

Overall survival

Description

Time Frame

participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months

Title

Neuropathic pain

Description

Time Frame

participants will be followed for the duration of chemotherapy and for at least 1 yaer after the completation of treatment, an expected average of 18 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 ≥ 1.5 x 109/L, platelets ≥ 100 x 109/L, and hemoglobin ≥ 9 g/dL Bilirubin level either normal or < 1.5 x ULN ASAT and ALAT < 2.5 x ULN (< 5 x ULN if liver metastasis are present) Serum creatinine <1.5 x ULN Written informed consent given before the randomization, according to International Conference on Harmonization/Good Clinical Practice (ICH/GCP) Exclusion Criteria: Symptomatic brain metastases Any investigational agent(s) 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lucio Crinò, MD

Organizational Affiliation

Azienda Ospedaliera di Perugia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Istituto Oncologico del Mediterraneo

City

Viagrande

State/Province

ZIP/Postal Code

95029

Country

Italy

Facility Name

Azienda Ospedaliera Ospedale S. Anna

City

Como

ZIP/Postal Code

22020

Country

Italy

Facility Name

Azienda Ospedaliera Istituti Ospitalieri

City

Cremona

ZIP/Postal Code

26100

Country

Italy

Facility Name

Azienda Ospedaliera di Desio e Vimercate - Presidio Ospedaliero di Desio

City

Desio

ZIP/Postal Code

20832

Country

Italy

Facility Name

Ospedale Civile

City

Guastalla

ZIP/Postal Code

42016

Country

Italy

Facility Name

Ospedale Alessandro Manzoni

City

Lecco

ZIP/Postal Code

23900

Country

Italy

Facility Name

Azienda Ospedaliera Ospedale Civile di Legnano

City

Legnano

ZIP/Postal Code

20025

Country

Italy

Facility Name

Azienda Ospedaliera Fatebenefratelli e Oftalmico

City

Milano

ZIP/Postal Code

20121

Country

Italy

Facility Name

Istituto Europeo Di Oncologia

City

Milano

ZIP/Postal Code

20141

Country

Italy

Facility Name

Azienda Ospedaliera San Paolo

City

Milano

ZIP/Postal Code

20142

Country

Italy

Facility Name

Azienda Ospedaliera Ospedale San Carlo Borromeo

City

Milano

ZIP/Postal Code

20153

Country

Italy

Facility Name

Azienda Ospedaliero Universitaria di Parma

City

Parma

ZIP/Postal Code

43126

Country

Italy

Facility Name

Fondazione Salvatore Maugeri

City

Pavia

ZIP/Postal Code

0381 33329

Country

Italy

Facility Name

Azienda Ospedaliera Perugia

City

Perugia

ZIP/Postal Code

06075

Country

Italy

Facility Name

Arcispedale S. Maria Nuova

City

Reggio Emilia

ZIP/Postal Code

42100

Country

Italy

Facility Name

IRCCS di Reggio Emilia

City

Reggio Emilia

ZIP/Postal Code

42123

Country

Italy

Facility Name

Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero di Saronno

City

Saronno

ZIP/Postal Code

21047

Country

Italy

Facility Name

Ospedale SS Annunziata - ASL1

City

Sassari

ZIP/Postal Code

07100

Country

Italy

Facility Name

Azienda Ospedaliera Valtellina e Valchiavenna , Presidio Ospedaliero di Sondrio

City

Sondrio

ZIP/Postal Code

23100

Country

Italy

Facility Name

Azienda Ospedaliera di Pavia, Ospedale Civile di Vigevano

City

Vigevano

ZIP/Postal Code

27029

Country

Italy

Facility Name

Azienda Ospedaliera di Desio e Vimercate - Presidio Ospedaliero di Vimercate

City

Vimercate

ZIP/Postal Code

20059

Country

Italy

12. IPD Sharing Statement

Learn more about this trial

Acetyl-L-carnitine in Combination With a Cisplatin-containing Chemotherapy as First Line Treatment of Advanced or Metastatic Non Small Cell Lung Cancer

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