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

Primary Purpose

Non-Small Cell Lung Cancer

Status

Terminated

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

gemcitabine

cisplatin

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring stage IIIB, Stage IV, chemotherapy, monotherapy, combination chemotherapy, poor performance status

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Azienda Ospedaliera S. Giuseppe Moscati, U.O. di Oncologia Medica
Ospedale Regionale Miulli, Divisione Medicina Interna Sezione Oncologica
Istituto Oncologico di Bari, U.O. di Oncologia Medica e Sperimentale
Istituto Scientifico S. Raffaele
Azienda Ospedaliera C. Poma
Istituto Oncologico Veneto
Ospedale E. Morelli
Ospedale Senatore Antonio Perrino
A.O. Ospedale Mater Domini, Oncoematologia Università Magna Grecia
Ospedale F. Veneziale
A.O. Vito Fazzi
Istituto Nazionale dei Tumori , Divisione di Oncologia Medica B
Ospedale Regional, Unità Operative di Oncologia
Ospedale San Camillo - Forlanini
Ospedale S. Felice a Cancello

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm B

Arm A

Arm Description

combination chemotherapy

monochemotherapy

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

change in performance status

toxicity

quality of life

objective response

progression free survival

Full Information

NCT ID

NCT00526643

First Posted

September 6, 2007

Last Updated

March 27, 2017

Sponsor

National Cancer Institute, Naples

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT00526643

Brief Title

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

Acronym

CAPPA-2

Official Title

Gemcitabine Versus Cisplatin and Gemcitabine in First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer in Poor Physical Condition (Performance Status 2)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Terminated

Why Stopped

scarce enrolment and presentation of positive results of similar study in June 2012.

Study Start Date

November 2007 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Cancer Institute, Naples

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

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

Non-Small Cell Lung Cancer

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

57 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm B

Arm Type

Experimental

Arm Description

combination chemotherapy

Arm Title

Arm A

Arm Type

Active Comparator

Arm Description

monochemotherapy

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

cisplatin 60 mg/m2 on day 1 for 4 cycles

Primary Outcome Measure Information:

Title

overall survival

Time Frame

one year

Secondary Outcome Measure Information:

Title

change in performance status

Time Frame

each cycle of chemotherapy

Title

toxicity

Time Frame

each cycle of chemotherapy and every 3 months thereafter

Title

quality of life

Time Frame

chemotherapy cycles 1 and 2

Title

objective response

Time Frame

at 6 weeks and 12 weeks

Title

progression free survival

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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)

Overall Study Officials: