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

This study has been completed.
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
First received: September 24, 2008
Last updated: February 11, 2015
Last verified: February 2015
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.

Condition Intervention Phase
Small Cell Lung Carcinoma
Drug: Adriamycin, cyclophosphamide, vindesine, valproic acid
Phase 2

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

Resource links provided by NLM:

Further study details as provided by European Lung Cancer Working Party:

Primary Outcome Measures:
  • Six-months progression-free survival [ Time Frame: The period between the day of registration and the date of first progression ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Survival [ Time Frame: Survival will be dated from the date of registration ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Every three cycles of chemotherapy ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]

Enrollment: 64
Study Start Date: September 2008
Study Completion Date: June 2014
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chemotherapy regimen (adriamycin, cyclophosphamide, vindesine) plus valproic acid
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00759824

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Brussels, Belgium, 1000
Department of Pneumology CHU Charleroi
Charleroi, Belgium, 6000
Department of Pneumology Hôpital Saint-Joseph
Gilly, Belgium, 6060
Hôpital Ambroise Paré
Mons, Belgium, 7000
Department of Pneumology Centre Hospitalier de Mouscron
Mouscron, Belgium, 7700
Sponsors and Collaborators
European Lung Cancer Working Party
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
  More Information

Additional Information:
Responsible Party: European Lung Cancer Working Party
ClinicalTrials.gov Identifier: NCT00759824     History of Changes
Other Study ID Numbers: 01081 
Study First Received: September 24, 2008
Last Updated: February 11, 2015
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by European Lung Cancer Working Party:
Small cell lung carcinoma
Valproic acid
Second-line chemotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Small Cell Lung Carcinoma
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Liposomal doxorubicin
Valproic Acid
Alkylating Agents
Antibiotics, Antineoplastic
Antimanic Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Central Nervous System Depressants
Enzyme Inhibitors
GABA Agents
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on May 25, 2016