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 is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
Information provided by (Responsible Party):
European Lung Cancer Working Party
ClinicalTrials.gov Identifier:
NCT00759824
First received: September 24, 2008
Last updated: January 28, 2013
Last verified: January 2013
  Purpose

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 ]

Estimated Enrollment: 43
Study Start Date: September 2008
Estimated Study Completion Date: June 2014
Estimated 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Nathalie Leclercq, RN 0032/2/5390496 nathalie.leclercq@bordet.be
Contact: Thierry Berghmans, MD 0032/2/5390496

Locations
Belgium
Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Thierry Berghmans, MD    0032/2/5390496      
Principal Investigator: Thierry Berghmans, MD         
Department of Pneumology CHU Charleroi Recruiting
Charleroi, Belgium, 6000
Contact: Jacques Lecomte, MD         
Principal Investigator: Jacques Lecomte, MD         
Department of Pneumology Hôpital Saint-Joseph Recruiting
Gilly, Belgium, 6060
Contact: Benoît Colinet, MD         
Principal Investigator: Benoît Colinet, MD         
Hôpital Ambroise Paré Recruiting
Mons, Belgium, 7000
Contact: Stéphane Holbrechts, MD         
Sub-Investigator: Patricia Wackenier, MD         
Principal Investigator: Stéphane Holbrechts, MD         
Department of Pneumology Centre Hospitalier de Mouscron Recruiting
Mouscron, Belgium, 7700
Contact: Christian Tulippe, MD         
Principal Investigator: Christian Tulippe, MD         
Sponsors and Collaborators
European Lung Cancer Working Party
Investigators
Study Chair: Thierry Berghmans, MD European Lung Cancer Working Party
  More Information

Additional Information:
No publications provided

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: January 28, 2013
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
Adriamycin
Cyclophosphamide
Vindesine
Second-line chemotherapy

Additional relevant MeSH terms:
Small Cell Lung Carcinoma
Lung Neoplasms
Carcinoma
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Cyclophosphamide
Liposomal doxorubicin
Doxorubicin
Vindesine
Valproic Acid
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Anticonvulsants

ClinicalTrials.gov processed this record on October 19, 2014