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

NCT00759824 | Completed Phase 2 DMC

• 1 other identifier: 01081
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 5

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

Keywords

Small cell lung carcinoma; Valproic acid; Adriamycin; Cyclophosphamide; Vindesine; Second-line chemotherapy

Outcome Measures

Primary Outcomes (1)

• Six-months progression-free survival

  The period between the day of registration and the date of first progression

Secondary Outcomes (3)

• Survival

  Survival will be dated from the date of registration

• Response rate

  Every three cycles of chemotherapy

• Toxicity

  After each course of chemotherapy and at the end of treatment

Study Arms (1)

1

EXPERIMENTAL

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

Drug: Adriamycin, cyclophosphamide, vindesine, valproic acid

Interventions

Adriamycin, cyclophosphamide, vindesine, valproic acid 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

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• European Lung Cancer Working Party: lead

Study Sites (5)

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

Brussels, 1000, Belgium

Location

Department of Pneumology CHU Charleroi

Charleroi, 6000, Belgium

Location

Department of Pneumology Hôpital Saint-Joseph

Gilly, 6060, Belgium

Location

Hôpital Ambroise Paré

Mons, 7000, Belgium

Location

Department of Pneumology Centre Hospitalier de Mouscron

Mouscron, 7700, Belgium

Location

Related Links

• (Click here for more information on the protocol)

MeSH Terms

Conditions

Small Cell Lung Carcinoma

Interventions

Doxorubicin; Cyclophosphamide; Vindesine; Valproic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Pentanoic Acids; Valerates; Acids, Acyclic; Carboxylic Acids; Fatty Acids, Volatile; Fatty Acids; Lipids

Study Officials

• Thierry Berghmans, MD

  European Lung Cancer Working Party

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2008
• First Posted: September 25, 2008
• Study Start: September 1, 2008
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: February 12, 2015

Record last verified: 2015-02

Locations

BE (5)