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Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer (GIP-1)

Primary Purpose

Pancreatic Cancer

Status

Unknown status

Phase

Phase 3

Locations

Italy

Study Type

Interventional

Intervention

gemcitabine

cisplatin

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring chemotherapy, advanced cancer, inoperable, Stage II, III, IV

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologic or cytologic diagnosis pancreatic cancer
inoperable stage II or stage III or IV disease(UICC, 1997)
Age 18 to 75 years
Karnofsky Performance status > 50
Signed informed consent

Exclusion Criteria:

Previous chemotherapy
Cerebral metastases
Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer
Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl
Creatinine value > upper normal limit
GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit in absence of hepatic metastases
Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease
Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs
Inability to provide informed consent
Inability to comply with follow-up.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

cisplatin + gemcitabine

gemcitabine

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

clinical benefit response

quality of life

objective response

time to progression

Full Information

NCT ID

NCT00813696

First Posted

December 22, 2008

Last Updated

December 22, 2008

Sponsor

Istituti Tumori Giovanni Paolo II

Collaborators

Gruppo Oncologico Italia Meridionale, Gruppo Italiano per lo studio dei Carcinomi dell'Apparato Digerente, Gruppo Oncologico Italiano di Ricerca Clinica, Cattedra di Endocrinochirurgia, Università di Verona

1. Study Identification

Unique Protocol Identification Number

NCT00813696

Brief Title

Gemcitabine or Gemcitabine and Cisplatin in the Treatment of Advanced Pancreatic Cancer

Acronym

GIP-1

Official Title

Gemcitabine vs Gemcitabine + Cisplatin in the Treatment of Advanced Pancreatic Cancer (Stage II III IV)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2008

Overall Recruitment Status

Unknown status

Study Start Date

April 2002 (undefined)

Primary Completion Date

March 2009 (Anticipated)

Study Completion Date

September 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Istituti Tumori Giovanni Paolo II

Collaborators

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the impact of the addition of cisplatin to gemcitabine in the treatment of patients with inoperable advanced pancreatic cancer.

6. Conditions and Keywords

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

Pancreatic Cancer

Keywords

chemotherapy, advanced cancer, inoperable, Stage II, III, IV

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

400 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

cisplatin + gemcitabine

Arm Title

Arm Type

Active Comparator

Arm Description

gemcitabine

Intervention Type

Drug

Intervention Name(s)

gemcitabine

Intervention Description

1000 mg/m2 IV weekly for 7 weeks. Starting at week 9, gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 4 weeks

Intervention Type

Drug

Intervention Name(s)

cisplatin

Intervention Description

25 mg/m2 IV on days 1, 8, and 15 every 4 weeks

Primary Outcome Measure Information:

Title

overall survival

Time Frame

9 months

Secondary Outcome Measure Information:

Title

clinical benefit response

Time Frame

baseline and at end of every cycle of therapy

Title

quality of life

Time Frame

baseline and at end of every cycle of therapy

Title

objective response

Time Frame

after 7 weeks of therapy

Title

time to progression

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologic or cytologic diagnosis pancreatic cancer inoperable stage II or stage III or IV disease(UICC, 1997) Age 18 to 75 years Karnofsky Performance status > 50 Signed informed consent Exclusion Criteria: Previous chemotherapy Cerebral metastases Previous malignancies in past 5 years excluding adequately treated basal or spinocellular skin cancers and insitu cervical cancer Leukocytes < 4000 or neutrophils < 2000 or platelets < 100000 or hemoglobin < 10 g/dl Creatinine value > upper normal limit GOT or GPT > 2.5 times upper normal limit or bilirubin > 1.5 times upper normal limit in absence of hepatic metastases Congestive heart failure, severe cardiac arrhythmias or coronary ischemic disease Other concurrent disease that would, in the investigator's opinion, contraindicate the use of the study drugs Inability to provide informed consent Inability to comply with follow-up.

Overall Study Officials: