• SCLC on the 2nd Line With Relapsed After Response to Chemotherapy GFPC 01-2013

  NCT02738346

  Unknown statusInterventionalPhase 3Updated Apr 25, 2016
• A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

  NCT00168896

  Unknown statusInterventionalPhase 2Phase 3Updated Feb 14, 2006
• Docetaxel - Carboplatin As Second Line Treatment in Patients with Small Cell Lung Cancer

  NCT00686985

  CompletedInterventionalPhase 2Updated Sep 20, 2024
• Comparison of Two Combination Chemotherapy Regimens in Treating Patients With Extensive-Stage Small Cell Lung Cancer

  NCT00057837

  CompletedInterventionalPhase 2Updated Jul 5, 2023
• Extensive Small Cell Lung Cancer Treatment Using An Investigational Drug Plus Chemotherapy In Chemotherapy-Naive Adults

  NCT00043927

  CompletedInterventionalPhase 3Updated Aug 21, 2013
• S0119: Combination Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer

  NCT00030433

  CompletedInterventionalPhase 2Updated Feb 15, 2013

ClinicalTrials.gov ID

NCT00418743

Lead Sponsor

Groupe Francais De Pneumo-CancerologieOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

138Estimated

Last Update Posted

Mar 9, 2010Estimated

Start Date

Dec 2005

Completion Date

May 2010Estimated

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.

Brief 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.

Detailed 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.

• Small Cell Lung Cancer

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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.

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Groupe Francais De Pneumo-CancerologieOTHER

Collaborators

Baxter Healthcare CorporationINDUSTRY

AmgenINDUSTRY

jcmouries@ch-bastia.fr+33495591080

pascal.thomas@chicas-gap.fr+33 4 92 40 61 26

f-blanchon@ch-meaux.fr+33 1 64 35 38 56