Neoplasms

Digestive System Diseases

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

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Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Irinotecan

Leucovorin

Fluorouracil

Oxaliplatin

Folfirinox

Topoisomerase I Inhibitors

Enzyme Inhibitors

Antidotes

Protective Agents

Folic Acid

Vitamin B Complex

Trace Elements

Folate

Vitamin B9

FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours

FOLFIRINOX

Autumn J McRee, MD

This single arm, multi-center phase II clinical trial will assess the safety and efficacy of FOLFIRINOX in the first-line setting in patients with unresectable locally advanced (ULA) and borderline resectable (BR) pancreatic cancer.

FOLFIRINOX regimen was recently presented at an international oncology meeting and represents a new standard in the treatment of metastatic pancreatic cancer for selected patients. With improved overall survival (OS) and response rates (RR) in the metastatic setting, we hypothesize that in patients with less tumor burden, this regimen will be safe and well tolerated, improve OS, progression free survival (PFS), and RR, and improve resectability rates, as compared to historical data from standard single agent gemcitabine therapy for unresectable locally advanced (ULA) patients and standard radiation with concurrent 5 fluorouracil (5FU) chemotherapy for borderline resectable (BR) patients. While both ULA and BR patients will be eligible for the present study, our primary objective concerns ULA patients, and we plan to enroll 45 patients in this group.

Patients meeting eligibility criteria will be consented and treated with FOLFIRINOX every 2 weeks (1 cycle = 4 weeks = 2 treatments). Patients will undergo repeat imaging (CT or MRI) every 2 cycles and reassessed for resectability of the tumor. All patients that are not able to undergo surgical resection, due to insufficient down-staging or patient preference, will continue on protocol-based therapy until disease progression, unacceptable toxicity, study withdrawal, or death.

FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

Phase II Single Arm Clinical Trial of FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer

Tumor markers (Ca19-9, CEA) will be measured at baseline, every eight weeks and at end of treatment, and will be correlated with outcomes resectability response (RR),disease control rate (DCR), progression free survival (PFS) and overall survival (OS).

All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the primary outcome of overall survival (OS).

All patients who receive at least Day 1 of FOLFIRINOX treatment will be evaluable and followed up for up to 3 years for the outcome of overall survival (OS)

Progression free survival will be measured from D1 of treatment until evidence of tumor progression (including clinical deterioration related to the underlying pancreatic cancer, as assessed by the investigator) or death from any cause. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions. Patients that are lost to follow-up will be censored

All patients who have received at least one cycle of treatment will be evaluated. Disease will be evaluated per Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) for target lesions and assessed by CT and/or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions.

Patients who drop out of the study prior to disease evaluation will not be evaluable for response unless the patient undergoes radiologic evaluation or their disease progresses clinically.

Disease control rate will be measured by the percentage of patients with responses (CR) and partial responses (PR) and stable disease (SD), per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI and/or CT: Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progression of Disease (POD); Complete Response (CR), Disappearance of all target lesions.

Rate of resectability will be evaluated by determining the percentage of patients who were initially deemed to have ULA or borderline resectable (BR) disease and, following any period of treatment, were subsequently deemed to have resectable disease and undergo surgical resection. The denominator will reflect all patients with ULA or BR disease.

UNC Lineberger Comprehensive Cancer Center

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* 5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Robin V. Johnson

Patients with unresectable locally advanced pancreatic cancer.

Median Overall Survival (OS) of FOLFIRINOX in Patients With Unresectable Locally Advanced (ULA) Pancreatic Cancer

Overall Survival for Borderline Resectable Patients

Progression Free Survival (PFS)

Objective Response Rate

Disease Control Rate (DCR)

Rate of Resectability (RR)

FOLFIRINOX given to all subjects

FOLFIRINOX: FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:

* Oxaliplatin (85 mg/m2)
* Leucovorin (400mg/ m2)
* Irinotecan (180 mg/m2)
* Fluorouracil (5FU) (400mg/m2)bolus then 2400 mg/m2 over 46 hours

Correlation of Tumor Markers (Ca19-9, CEA) With Outcomes (RR, DCR, PFS, and OS).

Overall Study

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Breast Neoplasms

Recurrence

Breast Diseases

Skin Diseases

Gemcitabine

Taxane

Antimetabolites

1000 mg/m2, intravenous (IV), day 1 and day 8 every 21 days

gemcitabine

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

To investigate efficacy, safety and PK of GEM monotherapy after prior chemotherapy with anthracycline and taxane regimen for patients with metastatic breast cancer

Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen

A Multicenter Study of LY188011 in Anthracyclines and Taxanes Pre-treated Metastatic/Recurrent Breast Cancer

Best response recorded from the start of treatment until disease progression/recurrence using Response Evaluation Criteria In Solid Tumors (RECIST) criteria that defines when participants improve ("respond"), stay the same ("stable"), or worsen ("progression") during treatment.

For responders, the minimum and maximum of the duration of complete response, duration of partial response, and duration of overall response were summarized, and the median of response duration and its 95% confidence interval were calculated using the Kaplan-Meier estimation.

Time from study enrollment to first date of disease progression. Time to disease progression was censored at date of death if death was due to other cause. The minimum and maximum of this parameter were summarized, and the median time to progression and its 95% confidence interval were calculated using the Kaplan-Meier estimation.

Results are reported as number of participants alive at one year.

maximum gemcitabine plasma concentration normalized to 1250 milligrams per square meter of gemcitabine.

Area under the gemcitabine plasma concentration-time curve from time zero to infinity. Gemcitabine dose was normalized to 1250 milligrams per square meter.

Eli Lilly and Company

Chief Medical Officer

Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.

Dose Level 1

Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.

Dose Level 2

Total

Age Continuous

Japan

0 - Fully Active

1 - Ambulatory, Restricted Strenuous Activity

Classifies patients according to their functional impairment. Scores range from 0 (Fully Active) to 5 (Death).

Eastern Cooperative Oncology Group (ECOG) Performance Status

Unknown

Human Epidermal Growth Factor Receptor 2 Expression Status

None

Present

Presence of Estrogen Hormone Receptor

Lung

Bone

Liver

Brain

Lymph Node

Skin

Other Sites

Metastasis could occur in more than one site, resulting in a higher sum for all categories in the arm/group than the overall number of participants in the arm/group.

Presence of Metastasis

Presence of Progesterone Hormone Receptor

<3 months

≥3 months and <6 months

≥6 months and <1 year

≥1 year and <2 years

≥2 years and <3 years

≥3 years before

Time of Latest Chemotherapy Completion

<1 year

≥3 years and <4 years

≥4 years and < 5 years

≥5 to <10 years

No Recurrence

Time to Recurrence

Height

Weight

Complete Response

Partial Response

Long Stable Disease

Stable Disease

Progressive Disease

Not Evaluable

Tumor Response

The 5 responding participants (complete response and partial response) at Dose Level 2.

Duration of Response

Time to Progressive Disease

Survival at 1 Year

12 participants with a mean gemcitabine dose of 1120 milligrams per square meter

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer	NCT01688336	Pancreatic Canc...	FOLFIRINOX	18 Years -	UNC Lineberger Comprehensive Cancer Center
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen	NCT00191269	Metastatic Brea...	gemcitabine gemcitabine	20 Years - 74 Years	Eli Lilly and Company
FOLFIRINOX for Unresectable Locally Advanced and Borderline Resectable Pancreatic Cancer	NCT01688336	Pancreatic Canc...	FOLFIRINOX	18 Years -	UNC Lineberger Comprehensive Cancer Center
Gemcitabine Monotherapy for Metastatic Breast Cancer After Anthracycline and Taxane Regimen	NCT00191269	Metastatic Brea...	gemcitabine gemcitabine	20 Years - 74 Years	Eli Lilly and Company

Spots Global Cancer Trial Database for regimen

Every month we try and update this database with for regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for regimen

Every month we try and update this database with for regimen cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for regimen cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.