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
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ClinicalTrials.gov Identifier: NCT00759824 |
Recruitment Status :
Completed
First Posted : September 25, 2008
Last Update Posted : February 12, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Small Cell Lung Carcinoma | Drug: Adriamycin, cyclophosphamide, vindesine, valproic acid | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 64 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | September 2008 |
Actual Primary Completion Date : | December 2013 |
Actual Study Completion Date : | June 2014 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Chemotherapy regimen (adriamycin, cyclophosphamide, vindesine) plus valproic acid
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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 |
- Six-months progression-free survival [ Time Frame: The period between the day of registration and the date of first progression ]
- Survival [ Time Frame: Survival will be dated from the date of registration ]
- Response rate [ Time Frame: Every three cycles of chemotherapy ]
- Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00759824
Belgium | |
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 |
Study Chair: | Thierry Berghmans, MD | European Lung Cancer Working Party |
Responsible Party: | European Lung Cancer Working Party |
ClinicalTrials.gov Identifier: | NCT00759824 |
Other Study ID Numbers: |
01081 |
First Posted: | September 25, 2008 Key Record Dates |
Last Update Posted: | February 12, 2015 |
Last Verified: | February 2015 |
Small cell lung carcinoma Valproic acid Adriamycin |
Cyclophosphamide Vindesine Second-line chemotherapy |
Small Cell Lung Carcinoma Lung Neoplasms Neoplasms Carcinoma, Bronchogenic Bronchial Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Lung Diseases Respiratory Tract Diseases Cyclophosphamide Doxorubicin Liposomal doxorubicin Vindesine Valproic Acid |
Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anticonvulsants GABA Agents |