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Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer (FRAGANCE)

Primary Purpose

Advanced Pancreatic Cancer

Status

Completed

Phase

Phase 1

Locations

Spain

Study Type

Interventional

Intervention

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

About this trial

This is an interventional treatment trial for Advanced Pancreatic Cancer focused on measuring Advanced pancreatic cancer, Fragile, Nab-paclitaxel

Eligibility Criteria

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

Inclusion Criteria:

Patients who are 18 years or older;
Patients with histological or, if not possible, cytologic confirmed adenocarcinoma of the pancreas.
Patients with metastatic pancreatic cancer;
Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2
Adequate hematopoietic, hepatic and renal function:
Neutrophil count >= 1.5 x 10*9/L;
Platelet count >= 100 x 10*9/L;
Bilirubin <= 1.5 x ULN;
AST and/or ALT <= 2.5 x ULN;
Serum creatinine <= 1.5 x ULN.
Investigators must ensure that patients enrolled in the study will be available for all study procedures, including tumor biopsy, chemotherapy treatment, and follow up.
Investigators must ensure that patients have the ability to understand the requirements of the study and provide signed informed consent.
Women of childbearing potential and men who wish to participate in the study must agree to use adequate contraception since the signing of informed consent until at least 3 months after stopping the study medication;
Signed Informed Consent.

Exclusion Criteria:

Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with patient eligibility for treatment;
History of any psychiatric condition that might impair patient?s ability to understand or to comply with the requirements of the study or to provide informed consent;
Concurrent anticancer therapy;
Pregnant or breast-feeding women (documented methods of birth control are required in those with reproductive potential);
History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs;
History of life threatening reaction to gemcitabine or abraxane;
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <=1.
Previous treatment with chemotherapy or chemoradiotherapy for advanced pancreatic cancer.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm B

Arm C

Arm D

Arm E

Arm Description

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Outcomes

Primary Outcome Measures

PHASE I: To select the schemes with the best therapeutic indexes of the combination of gemcitabine and nab-paclitaxel in fragile patients with advanced pancreatic cancer.

Phase I: Therapeutic index. Criteria: Early mortality all causes at 30 and 60 days, Adverse Events grade 3 and 4, treatment discontinuation due to toxicity and relative dose intensity

PHASE II: Evaluate the effectiveness of two selected schemes of gemcitabine and nab-paclitaxel, vs. gemcitabine alone. (Six months overall survival)

Six months overall survival

Secondary Outcome Measures

Phase I: evaluate safety profile of gemcitabine and nab-paclitaxel schemes. (Number of events per patient according to NCI-CTC-AE criteria)

Number of events per patient according to NCI-CTC-AE criteria

Phase I: evaluate objective response rate. (Response rate will be evaluated according RECIST criteria)

Response rate will be evaluated according RECIST criteria

Phase II: progression free survival (Time from randomization to disease progression according RECIST criteria)

Time from randomization to disease progression according RECIST criteria

Phase II: objective response rate (Response rate will be evaluated according RECIST criteria)

Response rate will be evaluated according RECIST criteria

Phase II: to explore changes induced by treatment on tumor Marker CA19.9

Phase II: change in FAP and Cav-1 tumor markers as an inidicatior of treatment efficacy

Full Information

NCT ID

NCT02382263

First Posted

February 24, 2015

Last Updated

July 5, 2016

Sponsor

PH Research, S.L.

1. Study Identification

Unique Protocol Identification Number

NCT02382263

Brief Title

Nab-paclitaxel in Combination With Gemcitabine in Fragile Patients With Advanced Pancreatic Cancer

Acronym

FRAGANCE

Official Title

Phase I/II Study to Assess the Efficacy and Safety of Nab-paclitaxel in Combination With Gemcitabine for the Treatment of Fragile Patients With Advanced or Metastatic Pancreatic Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Completed

Study Start Date

April 2013 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

PH Research, S.L.

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

In the list of cancer mortality by type of cancer pancreatic cancer ranks 4th in USA and the 6th in Europe. The estimated figures for 2010 in the USA were 42,000 new cases and 36,000 deaths from pancreatic cancer. The survival rate at 5 years after diagnosis is 4.6% in the USA. In Europe the figures are similar, with survival at 1, 3 and 5 years of 16%, 6% and 4%, respectively. Most patients are diagnosed in advanced stages that are no longer operable, so that treatment goals are often the prolongation of survival and palliation of symptoms. The aim of the study is to explore whether the new combination nab-paclitaxel plus gemcitabine is a therapeutic advance for this fragile population for which it is assumed that some modifications in dose and schedule of administration may be necessary in patients with good performance status. It is ultimately to find out the clinical benefit of this combination, but first making sure that dose and schedule of the combination are tolerable for these fragile patients. For this, the investigators have chosen a design that includes two stages: the first step aimed at choosing the safest treatment regimen for these patients among a group of treatment regimens used in other clinical trials. The second step will evaluate the effectiveness of the two regimens with the better results in the previous step.

6. Conditions and Keywords

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

Advanced Pancreatic Cancer

Keywords

Advanced pancreatic cancer, Fragile, Nab-paclitaxel

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

224 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm B

Arm Type

Experimental

Arm Description

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Arm Title

Arm C

Arm Type

Experimental

Arm Description

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Arm Title

Arm D

Arm Type

Experimental

Arm Description

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Arm Title

Arm E

Arm Type

Experimental

Arm Description

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Intervention Description

Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 & 15 in a 28 days cycle

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Intervention Description

Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4

Intervention Description

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 & 15 in a 28 days cycle

Intervention Type

Drug

Intervention Name(s)

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4

Intervention Description

Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle

Primary Outcome Measure Information:

Title

PHASE I: To select the schemes with the best therapeutic indexes of the combination of gemcitabine and nab-paclitaxel in fragile patients with advanced pancreatic cancer.

Description

Phase I: Therapeutic index. Criteria: Early mortality all causes at 30 and 60 days, Adverse Events grade 3 and 4, treatment discontinuation due to toxicity and relative dose intensity

Time Frame

Up to 2 months

Title

PHASE II: Evaluate the effectiveness of two selected schemes of gemcitabine and nab-paclitaxel, vs. gemcitabine alone. (Six months overall survival)

Description

Six months overall survival

Time Frame

Up to 6 months

Secondary Outcome Measure Information:

Title

Phase I: evaluate safety profile of gemcitabine and nab-paclitaxel schemes. (Number of events per patient according to NCI-CTC-AE criteria)

Description

Number of events per patient according to NCI-CTC-AE criteria

Time Frame

Up to 6 months

Title

Phase I: evaluate objective response rate. (Response rate will be evaluated according RECIST criteria)

Description

Response rate will be evaluated according RECIST criteria

Time Frame

Up to 6 months

Title

Phase II: progression free survival (Time from randomization to disease progression according RECIST criteria)

Description

Time from randomization to disease progression according RECIST criteria

Time Frame

Up to 8 months

Title

Phase II: objective response rate (Response rate will be evaluated according RECIST criteria)

Description

Response rate will be evaluated according RECIST criteria

Time Frame

Up to 6 months

Title

Phase II: to explore changes induced by treatment on tumor Marker CA19.9

Time Frame

Up to 8 months

Title

Phase II: change in FAP and Cav-1 tumor markers as an inidicatior of treatment efficacy

Time Frame

Up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who are 18 years or older; Patients with histological or, if not possible, cytologic confirmed adenocarcinoma of the pancreas. Patients with metastatic pancreatic cancer; Patient with an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) = 2 Adequate hematopoietic, hepatic and renal function: Neutrophil count >= 1.5 x 10*9/L; Platelet count >= 100 x 10*9/L; Bilirubin <= 1.5 x ULN; AST and/or ALT <= 2.5 x ULN; Serum creatinine <= 1.5 x ULN. Investigators must ensure that patients enrolled in the study will be available for all study procedures, including tumor biopsy, chemotherapy treatment, and follow up. Investigators must ensure that patients have the ability to understand the requirements of the study and provide signed informed consent. Women of childbearing potential and men who wish to participate in the study must agree to use adequate contraception since the signing of informed consent until at least 3 months after stopping the study medication; Signed Informed Consent. Exclusion Criteria: Active or uncontrolled infections or serious illnesses or medical conditions that could interfere with patient eligibility for treatment; History of any psychiatric condition that might impair patient?s ability to understand or to comply with the requirements of the study or to provide informed consent; Concurrent anticancer therapy; Pregnant or breast-feeding women (documented methods of birth control are required in those with reproductive potential); History of allergic reactions attributed to compounds of similar chemical or biologic composition to study drugs; History of life threatening reaction to gemcitabine or abraxane; Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) <=1. Previous treatment with chemotherapy or chemoradiotherapy for advanced pancreatic cancer.

Overall Study Officials: