CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

NCT ID: NCT00526643

Last Updated: 2017-03-28

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 57 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-11-30
• Study Completion Date: 2012-12-31

Brief Summary

The primary objective of this study is to evaluate the impact on overall survival (OS) of the addition of cisplatin to gemcitabine vs gemcitabine alone in patients with advanced NSCLC in poor clinical condition (PS 2), not previously treated.

Detailed Description

Performance status is one of the most important prognostic factors for patients with advanced non-small cell lung cancer (NSCLC), regardless of treatment received. Chemotherapy is recommended for advanced NSCLC patients in good clinical condition, but it is not clear how much benefit is gained from giving chemotherapy to patients in poor general condition (performance status 2). This category of patients represents about 20% of all patients at initial diagnosis of NSCLC, and remains a treatment challenge for the clinician. There have been very few studies that have evaluated the impact of chemotherapy for this group of patients, and there is no established standard therapy. Studies evaluating single agent and combination two-agent chemotherapy regimens' impact on survival and improving symptoms are needed.

Conditions

Non-Small Cell Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm B

combination chemotherapy

Group Type: EXPERIMENTAL

gemcitabine

Intervention Type: DRUG

1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

cisplatin

Intervention Type: DRUG

cisplatin 60 mg/m2 on day 1 for 4 cycles

Arm A

monochemotherapy

Group Type: ACTIVE_COMPARATOR

gemcitabine

Intervention Type: DRUG

1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

Interventions

gemcitabine

1200 mg/m2 intravenous infusion on days 1 and 8, every 3 weeks for a maximum of 4 cycles

Intervention Type: DRUG

cisplatin

cisplatin 60 mg/m2 on day 1 for 4 cycles

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV);
• No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment);
• ECOG performance status 2;
• Age: > or = 18 and < 70 years;
• Life expectancy at least 4 weeks;
• Normal bone marrow, hepatic and renal function defined as: neutrophils > or = 2000/mm3, PLT > or = 100,000/mm3, Hb > or = 10.0 g/dl, Bilirubin > or = 1.5 times the upper normal limit (UNL), AST and ALT < or = 3 times the UNL (5 times in the presence of liver metastases), creatinine within normal limits;
• Signed informed consent.

Exclusion Criteria

• Active systemic infections;
• Severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus);
• Inadequate hepatic or renal function;
• Radiation therapy ongoing or concluded within two weeks prior to enrollment;
• Symptomatic cerebral metastases;
• Previous chemotherapy for advanced disease;
• Any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures;
• Pregnant or nursing females;
• Any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clinical Trials Promoting Group (APRIC/CTPG)

UNKNOWN

Sponsor Role: collaborator

Gruppo Oncologico del Lazio (GOL)

UNKNOWN

Sponsor Role: collaborator

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

OTHER

Sponsor Role: collaborator

Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC)

UNKNOWN

Sponsor Role: collaborator

Gruppo Oncologico Italia Meridionale

OTHER

Sponsor Role: collaborator

Northwest Oncology Cooperative Group(GONO)

UNKNOWN

Sponsor Role: collaborator

National Cancer Institute, Naples

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cesare Gridelli, M.D.

Role: PRINCIPAL_INVESTIGATOR

APRIC/CTPG

Luciano Frontini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

Vittorio Gebbia, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gruppo Oncologico Italia Meridionale

Andrea Ardizzoni, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gruppo Oncologico Italiano di Ricerca Clinica

Filippo de Marinis, M.D.

Role: PRINCIPAL_INVESTIGATOR

GOL

Enrico Aitini, M.D.

Role: PRINCIPAL_INVESTIGATOR

Gruppo Oncologico del Nord-Ovest

Francesco Perrone, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute, Naples

Ciro Gallo, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Campania Luigi Vanvitelli

Locations

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica

Monteforte Irpino, AV, Italy

Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

Acquaviva delle Fonti, BA, Italy

Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale

Bari, BA, Italy

Istituto Scientifico S. Raffaele

Milan, MI, Italy

Azienda Ospedaliera C. Poma

Mantova, MN, Italy

Istituto Oncologico Veneto

Padua, PD, Italy

Ospedale E. Morelli

Sondalo, SO, Italy

Ospedale Senatore Antonio Perrino

Brindisi, , Italy

A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia

Catanzaro, , Italy

Ospedale F. Veneziale

Isernia, , Italy

A.O. Vito Fazzi

Lecce, , Italy

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, , Italy

Ospedale Regional, Unità Operative di Oncologia

Parma, , Italy

Ospedale San Camillo - Forlanini

Rome, , Italy

Ospedale S. Felice a Cancello

San Felice A Cancello, , Italy

Countries

Italy

References

Morabito A, Gebbia V, Di Maio M, Cinieri S, Vigano MG, Bianco R, Barbera S, Cavanna L, De Marinis F, Montesarchio V, Costanzo R, Sandomenico C, Montanino A, Mancuso G, Russo P, Nacci A, Giordano P, Daniele G, Piccirillo MC, Rocco G, Gridelli C, Gallo C, Perrone F. Randomized phase III trial of gemcitabine and cisplatin vs. gemcitabine alone in patients with advanced non-small cell lung cancer and a performance status of 2: the CAPPA-2 study. Lung Cancer. 2013 Jul;81(1):77-83. doi: 10.1016/j.lungcan.2013.04.008. Epub 2013 May 1.

Reference Type: RESULT

PMID: 23643177 (View on PubMed)

Gijtenbeek RG, de Jong K, Venmans BJ, van Vollenhoven FH, Ten Brinke A, Van der Wekken AJ, van Geffen WH. Best first-line therapy for people with advanced non-small cell lung cancer, performance status 2 without a targetable mutation or with an unknown mutation status. Cochrane Database Syst Rev. 2023 Jul 7;7(7):CD013382. doi: 10.1002/14651858.CD013382.pub2.

Reference Type: DERIVED

PMID: 37419867 (View on PubMed)

Other Identifiers

2005-005631-97

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CAPPA-2

Identifier Type: -

Identifier Source: org_study_id