Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC)

Small Cell Lung Cancer Clinical Trial

Official title:

A Phase II Randomised Trial of Second-line Treatment in Patients With Small Cell Lung Cancer (SCLC), Comparing Oral Combination Chemotherapy (CCNU, Cyclophosphamide, Etoposide) With Intravenous Association Chemotherapy.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00418743
• Other study ID #: GFPC 05-01
• Status: Recruiting
• Phase: Phase 2
• First received: January 4, 2007
• Last updated: March 8, 2010
• Start date: December 2005
• Est. completion date: May 2010

Study information

• Verified date: March 2010
• Source: Groupe Francais De Pneumo-Cancerologie
• Contact: Christos CHOUAID, Professor
• Phone: +33 1 49 28 25 16
• Email: christos.chouid[@]sat.ap-hop-paris.fr
• Is FDA regulated: No
• Health authority: France: Institutional Ethical Committee
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to determine treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Description:

Determined treatment efficacy and tolerability of second-line treatment in patients with small cell lung cancer comparing oral combinaison chemotherapy with intravenous combination chemotherapy.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Small-cell lung cancer.

• Patients who, after (at least) a first line of chemotherapy based on platinum, had a partial response and then progressed, or who had a complete response and then relapsed within three months following the last course of this first-line therapy.

• Measurable or assessable disease.

• Life expectancy >2 months.

• Patients with a therapeutic risk level of <5 points (see section 6: "Treatment flowchart").

• Age >18 years;

• Performance status (WHO) <2;

• One measurable target lesion in a non irradiated region;

• Prior radiotherapy authorized unless it targeted the only measurable lesion;

• Biological criteria: WBC >2000/mm3, PMN >1500/mm3, platelets >100 000/mm3, creatinemia <2 x ULN, bilirubinemia <ULN, ALT and AST <2.5 x ULN (< 5 N if liver metastases)

• normal ECG

• written informed consent.

Exclusion Criteria:

• Non small-cell lung cancer.

• No objective response to platinum-based therapy

• Complete response lasting more than three months after the last course of first-line treatment.

• Symptomatic brain metastases.

• Bone metastases, carcinomatous lymphangitis, ascites or pleurisy as sole assessable disease manifestations.- Concurrent participation in another clinical trial.

• Therapeutic risk level of 6 points or more (see table)

• Uncontrolled clotting disorders;

• Uncontrolled severe infection;

• History of another malignancy, except for cervical carcinoma in situ or basocellular cancer that are considered cured;

• Psychological, familial, sociological or geographic circumstances preventing treatment follow-up as defined in the protocol;

• Patients deprived of their rights for administrative or legal reasons.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Neoplasms
• Small Cell Lung Cancer
• Small Cell Lung Carcinoma

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Angers
France	Site 05	Bastia
France	Site 22	Beauvais
France	Centre Hospitalier du Morvan	Brest
France	Centre François Baclesse	Caen
France	Site 43	Caen
France	Centre Hospitalier René Dubos	Cergy-pontoise
France	Site 33	Creteil
France	Site 07	Draguignan
France	Site 32	Elbeuf
France	Site 04	GAP
France	Centre Hospitalier Les Oudairies	La Roche Sur Yon
France	Hospital du Cluzeau	Limoges
France	Centre Hospitalier Régional	Longjumeau
France	Centre Hospitalier Lyon Sud	Lyon
France	Site 25	Mantes La Jolie
France	Site 06	Marseille
France	Site 27	Martigues
France	Site 01	Meaux
France	Hospital Saint Antoine	Paris
France	Site 17	Rouen
France	Hôpital Yves Le Foll	Saint Brieuc
France	Site 14	Toulon
France	Site 11	Villefranche Sur Saone

Sponsors (3)

Lead Sponsor	Collaborator
Groupe Francais De Pneumo-Cancerologie	Amgen, Baxter Healthcare Corporation

Country where clinical trial is conducted

France, 

External Links

•   Groupement Francais de Pneumo-cancérologie