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NCT Number: NCT02382263

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

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.

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Key information

Conditions

Advanced Pancreatic Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Complexo Hospitalario Universitario A Coruña, A Coruña, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

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

Drug

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

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

Drug

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

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

Drug

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

Primary outcomes

  1. 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.

    Time frame: Up to 2 months

    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

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

    Time frame: Up to 6 months

    Six months overall survival

Secondary outcomes

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

    Time frame: Up to 6 months

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

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

    Time frame: Up to 6 months

    Response rate will be evaluated according RECIST criteria

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

    Time frame: Up to 8 months

    Time from randomization to disease progression according RECIST criteria

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

    Time frame: Up to 6 months

    Response rate will be evaluated according RECIST criteria

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

    Time frame: Up to 8 months

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

    Time frame: Up to 6 months

Sponsors and collaborators

Lead sponsor

PH Research, S.L.

Other

Registry information

Official study 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

Acronym: FRAGANCE

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Mar 6, 2015
Registry last updated
Jul 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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