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.
Verified January 2013 by European Lung Cancer Working Party
Sponsor:
European Lung Cancer Working Party
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Drug Information available for:
Cyclophosphamide
Valproic acid
Valproate sodium
Doxorubicin
Doxorubicin hydrochloride
Etoposide
Divalproex sodium
Etoposide phosphate
U.S. FDA Resources
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
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:
|
Carcinoma Lung Neoplasms Small Cell Lung Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms Valproic Acid Cyclophosphamide |
Doxorubicin Etoposide Vindesine Anticonvulsants Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action GABA Agents Neurotransmitter Agents Physiological Effects of Drugs Antimanic Agents Tranquilizing Agents Central Nervous System Depressants |
ClinicalTrials.gov processed this record on May 23, 2013