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Gemcitabine for Pancreatic Cancer

Johns Hopkins, Baltimore, MD
Pancreatic Cancer+9 More ConditionsGemcitabine - Drug
Eligibility
18 - 76
All Sexes
What conditions do you have?
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Study Summary

This trial is testing a combination of 5 drugs to treat metastatic pancreatic cancer.

Eligible Conditions
  • Pancreatic Cancer
  • Adenocarcinoma
  • Digestive System Tumors
  • Endocrine Disorders
  • Glandular Neoplasm
  • Tumors
  • Pancreatic Disease
  • Gastrointestinal Disorders
  • Endocrine Tumors

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 1 & 2

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Study Objectives

2 Primary · 4 Secondary · Reporting Duration: 4 years

4 years
Part 1: Percentage of participants experiencing toxicities
Part 2: Disease Control Rate (DCR)
Part 2: Overall survival (OS)
Part 2: Percentage of participants experiencing toxicities with GAX-CI (gemcitabine, nab-paclitaxel, capecitabine, cisplatin, and irinotecan, a combinatorial therapy).
Part 2: Progression Free Survival (PFS)
Part 2: Response Rate (RR)

Trial Safety

Phase-Based Safety

1 of 3

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Side Effects for

Gemcitabine Plus Cisplatin (GC)
51%Neutropenia
47%Leukopenia
46%Nausea
43%Vomiting
35%Anaemia
31%Decreased appetite
26%Haemoglobin decreased
26%Fatigue
25%Constipation
25%White blood cell count decreased
24%Neutrophil count decreased
19%Alanine aminotransferase increased
13%Platelet count decreased
12%Rash
10%Thrombocytopenia
10%Aspartate aminotransferase increased
9%Blood sodium decreased
8%Hypokalaemia
7%Pyrexia
7%Insomnia
6%Blood creatinine increased
6%Hyponatraemia
6%Cough
6%Lymphopenia
6%Diarrhoea
6%Dyspepsia
6%Red blood cell count decreased
4%Dizziness
2%Bone marrow failure
1%Superior vena cava syndrome
1%Dyspnoea
1%Embolism venous
1%Cerebral infarction
1%Pulmonary embolism
1%Ischaemic stroke
This histogram enumerates side effects from a completed 2012 Phase 3 trial (NCT01005680) in the Gemcitabine Plus Cisplatin (GC) ARM group. Side effects include: Neutropenia with 51%, Leukopenia with 47%, Nausea with 46%, Vomiting with 43%, Anaemia with 35%.

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

Trial Design

2 Treatment Groups

Cohort 2
1 of 2
Cohort 1
1 of 2

Experimental Treatment

86 Total Participants · 2 Treatment Groups

Primary Treatment: Gemcitabine · No Placebo Group · Phase 1 & 2

Cohort 2Experimental Group · 5 Interventions: Capecitabine, Gemcitabine, Nab-paclitaxel, Irinotecan, Cisplatin · Intervention Types: Drug, Drug, Drug, Drug, Drug
Cohort 1Experimental Group · 5 Interventions: Capecitabine, Gemcitabine, Nab-paclitaxel, Irinotecan, Cisplatin · Intervention Types: Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Capecitabine
FDA approved
Gemcitabine
FDA approved
Paclitaxel
FDA approved
Irinotecan
FDA approved
Cisplatin
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 years

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
539 Previous Clinical Trials
30,979 Total Patients Enrolled
Dung Le, MDPrincipal InvestigatorJohns Hopkins Medical Institution
12 Previous Clinical Trials
623 Total Patients Enrolled

Eligibility Criteria

Age 18 - 76 · All Participants · 0 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
References

Frequently Asked Questions

How can I qualify to be a part of this clinical research?

"This study requires that potential participants are between 18 and 76 years old, have cancer, and meet one or more of the following conditions: having at least one measurable lesion, being in good physical condition as determined by the ECOG performance status (0 or 1), using birth control while on the medication, and being a male or non-pregnant/non-lactating female over 18 years old." - Anonymous Online Contributor

Unverified Answer

What are researchers hoping to discover through this clinical trial?

"The primary objective of this medical trial, which will be conducted over the course of approximately 4 years, is to assess Progression Free Survival (PFS). Additionally, researchers will also measure secondary outcomes including toxicity levels among participants receiving GAX-CI therapy, overall survival rates, and response rates." - Anonymous Online Contributor

Unverified Answer

Is Gemcitabine a new medication?

"Gemcitabine is being studied in 2032 active clinical trials, with 604 of those studies classified as Phase 3. Many research centres are situated in Guangzhou, Guangdong; however, there are 95435 total locations conducting Gemcitabine trials worldwide." - Anonymous Online Contributor

Unverified Answer

How many individuals are allowed to enroll in this research project?

"That is right, the public information available on clinicaltrials.gov suggests that this study is actively recruiting patients. The listing was created on June 21st, 2018 and updated as recently as March 15th, 2022. This particular trial requires 86 individuals at 2 separate locations." - Anonymous Online Contributor

Unverified Answer

Are we recruiting participants who are middle-aged for this research?

"This specific trial is for individuals aged 18 to 76. 514 studies are available for people younger than this age bracket, while 5552 studies focus on patients above the age of 65." - Anonymous Online Contributor

Unverified Answer

Are patients being actively recruited for this research project?

"This is an ongoing clinical trial, as reflected by the postings on clinicaltrials.gov. Candidates are actively being sought for the trial which was first posted on 6/21/2018 and last edited on 3/15/2022." - Anonymous Online Contributor

Unverified Answer

What are the most popular conditions that Gemcitabine has been known to alleviate?

"Gemcitabine is a medication that is mostly used to treat patients with locally advanced non-small cell lung cancer, however it can also be effective for those suffering from metastatic bladder cancer, urinary bladder, and advanced testicular cancer." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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