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

Small Cell Lung Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759824
• Other study ID #: 01081
• Status: Completed
• Phase: Phase 2
• First received: September 24, 2008
• Last updated: February 11, 2015
• Start date: September 2008
• Est. completion date: June 2014

Study information

• Verified date: February 2015
• Source: European Lung Cancer Working Party
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health Products
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: June 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Carcinoma

Intervention

Drug:
• Adriamycin, cyclophosphamide, vindesine, valproic acid
Adriamycin 45 mg/m² day 1 IV Cyclophosphamide 1 g/m² day 1 IV Vindesine 3 mg/m² day 1 IV Valproic acid 20-30 mg/kg/day from day -7 until the end of treatment, orally

Locations

Country	Name	City	State
Belgium	Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet	Brussels
Belgium	Department of Pneumology CHU Charleroi	Charleroi
Belgium	Department of Pneumology Hôpital Saint-Joseph	Gilly
Belgium	Hôpital Ambroise Paré	Mons
Belgium	Department of Pneumology Centre Hospitalier de Mouscron	Mouscron

Sponsors (1)

Lead Sponsor	Collaborator
European Lung Cancer Working Party

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six-months progression-free survival		The period between the day of registration and the date of first progression	Yes
Secondary	Survival		Survival will be dated from the date of registration	No
Secondary	Response rate		Every three cycles of chemotherapy	No
Secondary	Toxicity		After each course of chemotherapy and at the end of treatment	No

External Links

•   (Click here for more information on the protocol)