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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

Primary Purpose

Small Cell Lung Carcinoma

Status

Completed

Phase

Phase 2

Locations

Belgium

Study Type

Interventional

Intervention

Adriamycin, cyclophosphamide, vindesine, valproic acid

About this trial

This is an interventional treatment trial for Small Cell Lung Carcinoma focused on measuring Small cell lung carcinoma, Valproic acid, Adriamycin, Cyclophosphamide, Vindesine, Second-line chemotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet
Department of Pneumology CHU Charleroi
Department of Pneumology Hôpital Saint-Joseph
Hôpital Ambroise Paré
Department of Pneumology Centre Hospitalier de Mouscron

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

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

Outcomes

Primary Outcome Measures

Six-months progression-free survival

Secondary Outcome Measures

Survival

Response rate

Toxicity

Full Information

NCT ID

NCT00759824

First Posted

September 24, 2008

Last Updated

February 11, 2015

Sponsor

European Lung Cancer Working Party

1. Study Identification

Unique Protocol Identification Number

NCT00759824

Brief 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

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 Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

September 2008 (undefined)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

June 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

European Lung Cancer Working Party

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Small Cell Lung Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Adriamycin, cyclophosphamide, vindesine, valproic acid

Intervention Description

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

Primary Outcome Measure Information:

Title

Six-months progression-free survival

Time Frame

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

Secondary Outcome Measure Information:

Title

Survival

Time Frame

Survival will be dated from the date of registration

Title

Response rate

Time Frame

Every three cycles of chemotherapy

Title

Toxicity

Time Frame

After each course of chemotherapy and at the end of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thierry Berghmans, MD

Organizational Affiliation

European Lung Cancer Working Party

Official's Role

Study Chair

Facility Information:

Facility Name

Department of Intensive Care Unit and Thoracic Oncology Institut Jules Bordet

City

Brussels

ZIP/Postal Code

1000

Country

Belgium

Facility Name

Department of Pneumology CHU Charleroi

City

Charleroi

ZIP/Postal Code

6000

Country

Belgium

Facility Name

Department of Pneumology Hôpital Saint-Joseph

City

Gilly

ZIP/Postal Code

6060

Country

Belgium

Facility Name

Hôpital Ambroise Paré

City

Mons

ZIP/Postal Code

7000

Country

Belgium

Facility Name

Department of Pneumology Centre Hospitalier de Mouscron

City

Mouscron

ZIP/Postal Code

7700

Country

Belgium

12. IPD Sharing Statement

Learn more about this trial

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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