Clinical trial NCT00759824: A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide
Official title: A Phase II Study of Doxorubicin, Cyclophosphamide and Vindesine With Valproic Acid in Patients With Refractory or Relapsing Small Cell Lung Cancer After Platinum Derivatives and Etoposide
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small Cell Lung Carcinoma
Keywords: Small cell lung carcinoma
Valproic acid
Adriamycin
Cyclophosphamide
Vindesine
Second-line chemotherapy
Lead sponsor: European Lung Cancer Working Party
Sponsor class: OTHER
First posted: 2008-09-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim of this study is to determine if the addition of valproic acid to a combination of adriamycin, cyclophosphamide and vindesine could increase progression-free survival in patients relapsing after first-line chemotherapy including platinum derivatives, cisplatin or carboplatin, and etoposide.


Eligibility criteria: Inclusion Criteria:

* Histological or cytological diagnosis of small-cell lung cancer (SCLC)
* SCLC refractory to prior chemotherapy regimen including platinum derivatives (cisplatin or carboplatin) and etoposide, either primary refractory (immediate progression or recurrence less than 3 months after the end of previous chemotherapy) or secondary refractory (sensitive patients to platinum plus etoposide in first-line, progressing or recurring less than 3 months after reintroduction of the same chemotherapy).
* At least one evaluable or measurable lesion
* Availability for participating in the detailed follow-up of the protocol
* Signed informed consent.

Exclusion Criteria:

* Patient who were previously treated with anthracyclin or vinca-alcaloid derivatives or cyclophosphamide
* Performance status \< 60 on the Karnofsky scale
* A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix or of the bladder or cured malignant tumour (more than 5-year disease free interval)
* A history of prior HIV infection
* Polynuclear cells \< 2,000/mm³
* Platelet cells \< 100,000/mm³
* Abnormal coagulation tests (aPTT, PTT, prothrombin time) and/or decreased fibrinogen
* Serum bilirubin \>1.5 mg/100 ml
* Transaminases more than twice the normal range
* Serum creatinine \> 1.5 mg/100 ml
* Recent myocardial infarction (less than 3 months prior to date of diagnosis)
* Congestive cardiac failure (ejection fraction of the left ventricle \< 50%) or uncontrolled cardiac arrhythmia
* Uncontrolled infectious disease
* Active epilepsy needing a specific treatment
* Concomitant treatment with IMAO, carbamazepine, mefloquine, phenobarbital, primidone, phenytoïn, lamotrigine, zidovudine
* Pregnancy or refusal to use active contraception
* A known allergy to valproic acid and/or doxorubicin, cyclophosphamide, vindesine
* Serious medical or psychological factors which may prevent adherence to the treatment schedule.

Primary outcomes:
measure: Six-months progression-free survival
timeFrame: The period between the day of registration and the date of first progression
Secondary outcomes:
measure: Survival
timeFrame: Survival will be dated from the date of registration
measure: Response rate
timeFrame: Every three cycles of chemotherapy
measure: Toxicity
timeFrame: After each course of chemotherapy and at the end of treatment
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
city: Charleroi
country: Belgium
facility: Department of Pneumology CHU Charleroi
city: Gilly
country: Belgium
facility: Department of Pneumology Hôpital Saint-Joseph
city: Mons
country: Belgium
facility: Hôpital Ambroise Paré
city: Mouscron
country: Belgium
facility: Department of Pneumology Centre Hospitalier de Mouscron
Study officials:
affiliation: European Lung Cancer Working Party
name: Thierry Berghmans, MD
role: STUDY_CHAIR
References: