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

NCT ID: NCT00759824

Last Updated: 2015-02-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-06-30

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.

Conditions

Small Cell Lung Carcinoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Chemotherapy regimen (adriamycin, cyclophosphamide, vindesine) plus valproic acid

Group Type: EXPERIMENTAL

Adriamycin, cyclophosphamide, vindesine, valproic acid

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

European Lung Cancer Working Party

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thierry Berghmans, MD

Role: STUDY_CHAIR

European Lung Cancer Working Party

Locations

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, , Belgium

Countries

Belgium

Related Links

http://www.elcwp.org

(Click here for more information on the protocol)

Other Identifiers

01081

Identifier Type: -

Identifier Source: org_study_id