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CBPC Aventis : bronches phase III
Title
Sponsor
Medical coodinator
Objectives
Methodology
Treatment
Criterias for inclusions
Duration of study
Number of patients
Title

Open label, randomised multicentre phase III study of Irinotecan hydrochloride (Campto Ò) and Cisplatin versus Etoposide and Cisplatin in chemotherapy naive patients with extensive disease - small cell lung cancer.
Sponsor

Laboratoire Aventis
Medical coodinator

Dr JF Morère – CH d’Avicennes - Bobigny
Objectives

Primary:  To compare efficacy (survival) of Irinotecan hydrochloride with Cisplatin versus Etoposide with Cisplatin as first line chemotherapy in patients with ED-SCLC.

Secondary:  To assess tolerance, overall response rate and duration of response, tumor related symptoms, quality of life.

Ancillary:  To collect socio-economic data in order to perform analyses by country.
Methodology

Open label, randomised multicentre phase III study.

There will be a central randomisation, patients will be stratified according to their performance status (0,1 vs 2) at study entry.
Treatment

Treatment arm A :

Irinotecan, HCl :            

80 mg/m²  

day 1,8


Cisplatin :           

80 mg/m²  

day 1
Both drugs repeated every 3 weeks.

Treatment arm B :

Etoposide :           

100 mg/m²  

day 1,2,3


Cisplatin :             

80 mg/m²           

day 1
Both drugs repeated every 3 weeks.

Prophylactic regimen :

Patients treated in arms A & B should be adequately hydrated and receive adequate anti-emetic regimen.
Patients treated with Irinotecan (arm A) : premedication with atropine is recommended in subsequent cycles if the patient experienced an acute and severe cholinergic syndrome at any cycle.

Criterias for inclusions

Inclusion criteria :

- Consent form obtained, signed and dated before beginning specific protocol procedures.

 

Histology and staging disease :

- Histologically or cytologically proven SCLC;

- Newly diagnosed SCLC

- Extensive disease SCLC (not candidate to curative lung and mediastinal radiotherapy).

General conditions :

- Age :  from 18 to 75 years;

- WHO performance status :  0, 1, 2;

- Life expectancy :  3 months or more;

- Adequate bone marrow function :
Hb
³ 10 g/dl and no blood cell transfusion within the previous 2 weeks;
Absolute neutrophil count
³ 2.0 x 109/l;
Platelets
³ 100 ´ 109/l;

- Adequate renal function :
 Creatinine
£ upper normal limit (UNL) or £ 100 m
mol/l.
If plasmatic creatinine value is
³ 100m
mol/l,
actual creatinine clearance should be
³ 60 ml/min;

- Adequate hepatic function :
Total bilirubin
£
1.5 x UNL,
AST (SGOT) and ALT (SGPT) £ 2.5
´
UNL,
Alkaline phosphatase
£ 5 x UNL;

- Serum magnesium should be within the normal value;

- Serum calcium £ UNL;

- At least one measurable and/or evaluable lesion, according to the RECIST criteria.

Prior therapy :

- previous radiotherapy is allowed only on bone metastases;

- no prior surgery on the primary tumor

- no prior chemotherapy for SCLC or for any other kind of disease

Initial work-up :

- Complete initial work-up within 21 days prior to the first infusion for imaging procedures and within 7 days prior to the first infusion for clinical evaluation and biological work-up.

Other :

- Able to comply with scheduled follow-up and with management of toxicity.

 

Non inclusion criteria :

 

General conditions :

- Pregnant or lactating patients;

- Patients (M/F) with reproductive potential not implementing adequate contraceptive methods;

- Previous systemic chemotherapy or immunotherapy for any reason;

- Chronic inflammatory bowel disease (Crohn’s disease or ulcerative colitis) and unresolved bowel obstruction (or sub-obstruction). History extensive intestinal resection (> hemicolectomy or extensive small intestine resection with chronic diarrhea).

 

Prior or current history:

- Symptomatic peripheral neuropathy and neuro-hearing grade > 2 NCI-CTC criteria except if due to trauma or mechanical impairment due to tumor mass;

- Patients with symptomatic brain metastases (despite adequate corticosteroid treatment)

- Active infection (infection requiring I.V antibiotics), including active tuberculosis;

- Active disseminated intravascular coagulation;

- Past or current history of neoplasm except for curatively treated non melanoma skin cancer or in situ carcinoma of the cervix or other cancer curatively treated and with no evidence of disease for at least 5 years;

- Pre-existing ascites NCI grade ³ 2 and / or pericardial effusion NCI grade ³ 2;

- Patient with compression spinal cord

- Any other severe condition:

-      Unstable cardiac disease despite treatment, myocardial infarction within 6 months prior to study entry, congestive heart disease, uncontrolled cardiac insufficiency;

-      superior vena cava syndrome contra-indicating hydration;

-      History of significant neurologic or psychiatric disorders including dementia, seizures, bipolar disorder;

- Other severe underlying medical conditions, which could impair the ability of the patient to participate in the study as cirrhosis, active peptic ulcer, unstable diabetes mellitus.

Concomitant treatments:

- Previous or concomitant treatment with any other experimental anti-cancer therapy;

- Concomitant or within 4 week period administration of any other experimental drug under investigation;

- History of allergy to one of the excipients of Irinotecan hydrochloride.

- Patients who have previously been treated with the investigational product

Other:

- Hypercalcemia (³ grade 1) not controlled by the use of bisphosphonates (IV);

- Patients clearly intending to withdraw from the study if not randomised in a given arm or patients who cannot be regularly followed up for psychological, social, familial or geographic reasons;

- Usual contra-indications to the use of atropine sulfate subcutaneously;

- Patient with expected non-compliance to toxicity management guidelines.


Duration of study

Planned duration of the study : 28 months

Planned enrollment duration : 15 months

The patients will be treated up to 6 cycles until tumor progression, or consent withdrawal or unacceptable side effects and then will be followed every 2 months for at least 36 months or until death if it occurs earlier. A minimum of 13 months is mandatory between the last patient enrollment and the cutoff date.
Number of patients

A total of 350 patients (209 / arm) should be included to show a significant survival superiority using a two-tailed logrank test with an alpha level of 4.87% and a power of 80%, assuming an increase in one-year survival from 38% to 50%, with an accrual period of 15 months and a minimum follow-up of 13 months.  The total number of patients takes into account a loss to follow-up rate of 5%.
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