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

NCT00526643 | Terminated Phase 3

• 2 other identifiers: CAPPA-22005-005631-97
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 15

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.

Conditions

Non-Small Cell Lung Cancer

Keywords

stage IIIB; Stage IV; chemotherapy; monotherapy; combination chemotherapy; poor performance status

Outcome Measures

Primary Outcomes (1)

• overall survival

  one year

Secondary Outcomes (5)

• change in performance status

  each cycle of chemotherapy

• toxicity

  each cycle of chemotherapy and every 3 months thereafter

• quality of life

  chemotherapy cycles 1 and 2

• objective response

  at 6 weeks and 12 weeks

• progression free survival

  one year

Study Arms (2)

Arm B

EXPERIMENTAL

combination chemotherapy

Drug: gemcitabine; Drug: cisplatin

Arm A

ACTIVE COMPARATOR

monochemotherapy

Drug: gemcitabine

Interventions

gemcitabine DRUG

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

Arm A; Arm B

cisplatin DRUG

cisplatin 60 mg/m2 on day 1 for 4 cycles

Arm B

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Cancer Institute, Naples: lead
• Clinical Trials Promoting Group (APRIC/CTPG): collaborator
• Gruppo Oncologico del Lazio (GOL): collaborator
• Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente: collaborator
• Gruppo Oncologico Italiano di Ricerca Clinica(GOIRC): collaborator
• Gruppo Oncologico Italia Meridionale: collaborator
• Northwest Oncology Cooperative Group(GONO): collaborator

Study Sites (15)

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

Monteforte Irpino, AV, 83024, Italy

Location

Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica

Acquaviva delle Fonti, BA, 70021, Italy

Location

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

Bari, BA, 70126, Italy

Location

Istituto Scientifico S. Raffaele

Milan, MI, 20132, Italy

Location

Azienda Ospedaliera C. Poma

Mantova, MN, 46100, Italy

Location

Istituto Oncologico Veneto

Padua, PD, Italy

Location

Ospedale E. Morelli

Sondalo, SO, 23039, Italy

Location

Ospedale Senatore Antonio Perrino

Brindisi, Italy

Location

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

Catanzaro, Italy

Location

Ospedale F. Veneziale

Isernia, Italy

Location

A.O. Vito Fazzi

Lecce, Italy

Location

Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B

Napoli, 80131, Italy

Location

Ospedale Regional, Unità Operative di Oncologia

Parma, Italy

Location

Ospedale San Camillo - Forlanini

Rome, Italy

Location

Ospedale S. Felice a Cancello

San Felice A Cancello, Italy

Location

Related Publications (2)

• 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.

  PMID: 23643177 RESULT

• 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.

  PMID: 37419867 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Gemcitabine; Cisplatin

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)

Heterocyclic Compounds; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds

Study Officials

• Cesare Gridelli, M.D.

  APRIC/CTPG

  PRINCIPAL INVESTIGATOR

• Luciano Frontini, M.D.

  Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente

  PRINCIPAL INVESTIGATOR

• Vittorio Gebbia, M.D.

  Gruppo Oncologico Italia Meridionale

  PRINCIPAL INVESTIGATOR

• Andrea Ardizzoni, M.D.

  Gruppo Oncologico Italiano di Ricerca Clinica

  PRINCIPAL INVESTIGATOR

• Filippo de Marinis, M.D.

  GOL

  PRINCIPAL INVESTIGATOR

• Enrico Aitini, M.D.

  Gruppo Oncologico del Nord-Ovest

  PRINCIPAL INVESTIGATOR

• Francesco Perrone, M.D., Ph.D.

  National Cancer Institute, Naples

  PRINCIPAL INVESTIGATOR

• Ciro Gallo, M.D., Ph.D.

  University of Campania Luigi Vanvitelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2007
• First Posted: September 10, 2007
• Study Start: November 1, 2007
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: March 28, 2017

Record last verified: 2017-03

Locations

IT (15)