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Antimetabolite

Chemotherapy + Rucaparib for Digestive System Cancers

Phase 1 & 2
Waitlist Available
Led By Tanios S Bekaii-Saab
Research Sponsored by Academic and Community Cancer Research United
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with metastatic disease from gastroesophageal cancer who received no more than 1 line of prior therapy in the metastatic setting
Patients with metastatic disease from biliary tract cancer who received no more than 1 line of prior therapy in the metastatic setting NOTE: No prior exposure to irinotecan in the metastatic setting will be allowed except in the phase I dose escalation portion and in colon cancer patients only; in pancreas cancer, exposure to irinotecan is only allowed in the neoadjuvant setting and no progressive disease < 3 months from last dose of irinotecan
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trial is studying the side effects of a combination of drugs, liposomal irinotecan, rucaparib, fluorouracil, and leucovorin calcium, in treating patients with pancreatic, colorectal, gastroesophageal, or biliary cancer that has spread to other places in the body.

Who is the study for?
This trial is for adults with certain metastatic cancers (pancreatic, colorectal, gastroesophageal, or biliary) who've had limited prior treatments. They must have a good performance status and adequate organ function. Pregnant or nursing individuals can't join, nor those with HIV on antiretrovirals, other recent cancers, severe diseases that could interfere with the study, or if they've had specific treatments like PARP inhibitors.Check my eligibility
What is being tested?
The trial tests liposomal irinotecan and rucaparib combined with fluorouracil and leucovorin calcium to see how well they treat metastatic digestive system cancers. It aims to find the best dose of these drugs together while assessing their effectiveness against tumor growth.See study design
What are the potential side effects?
Potential side effects include nausea, vomiting, diarrhea from chemotherapy drugs; fatigue; blood count changes; liver enzyme alterations; allergic reactions; and fertility issues due to rucaparib. There's also a risk of heart rhythm problems (QTc prolongation).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have gastroesophageal cancer and received only one prior treatment for it in the metastatic stage.
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I have biliary tract cancer with one prior treatment in the metastatic stage and no recent irinotecan.
Select...
I have pancreatic cancer and have had only one prior treatment for it in the metastatic stage.
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My liver enzyme levels are within the required range for my condition.
Select...
I have pancreatic cancer with metastasis and received 2 or fewer treatments.
Select...
I have biliary tract cancer with metastasis and received only one prior treatment.
Select...
I have a certain type of cancer and have had no more than 2 treatments for it after it spread.
Select...
I have colorectal cancer that has spread, and I've had up to 3 treatments for it.
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I have pancreatic cancer with specific genetic markers and haven't had treatment for it in its advanced stage.
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My kidney function, measured by creatinine or clearance, is within the required range.
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I am using or willing to use effective birth control or practice abstinence.
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I am currently using a progesterone-only contraceptive like Depo Provera, Implanon, or Nexplanon.
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I have pancreatic cancer with specific genetic markers and haven't had treatment for it in its advanced stage.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have gastroesophageal cancer and received only one prior treatment for it in the metastatic stage.
Select...
I have colorectal cancer that has spread, and I've had 3 or fewer treatments for it.
Select...
I stopped my previous chemotherapy more than 28 days ago.
Select...
My fallopian tubes are surgically blocked.
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My cancer can be measured by tests.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Best response rate (Phase II)
Number of participants with dose limiting toxicities (Phase I)
Objective response (Phase Ib)
Secondary outcome measures
Disease control rate (DCR)
Incidence of adverse events (Phase II)
Overall survival (Phase II)
+1 more

Side effects data

From 2022 Phase 3 trial • 564 Patients • NCT01968213
76%
Nausea
70%
Combined Asthenia/Fatigue
52%
Fatigue
39%
Combined Anaemia and/or decreased hemoglobin
38%
Constipation
38%
Vomiting
37%
Anaemia
35%
Diarrhoea
35%
Alanine aminotransferase increased
34%
Combined ALT/AST increased
33%
Abdominal pain
31%
Dysgeusia
29%
Combined Thrombocytopenia and/or decreased platelets
27%
Aspartate aminotransferase increased
25%
Decreased appetite
23%
Asthenia
22%
Arthralgia
20%
Headache
19%
Combined Neutropenia and/or decreased ANC
19%
Photosensitivity reaction
18%
Cough
17%
Thrombocytopenia
17%
Blood creatinine increased
16%
Dyspepsia
16%
Insomnia
16%
Dizziness
15%
Rash
15%
Pruritus
15%
Dyspnoea
15%
Abdominal pain upper
15%
Back pain
15%
Pyrexia
14%
Platelet count decreased
14%
Neutropenia
13%
Abdominal distension
13%
Upper respiratory tract infection
12%
Hypertension
12%
Oedema peripheral
12%
Hypomagnesaemia
10%
Nasopharyngitis
10%
Alopecia
10%
Taste disorder
10%
Dry skin
10%
Urinary tract infection
9%
Mucosal inflammation
9%
Influenza
9%
Depression
9%
Stomatitis
9%
Erythema
8%
Neutrophil count decreased
8%
Anxiety
8%
Hypercholesterolaemia
8%
Dry mouth
8%
Weight decreased
7%
Myalgia
7%
Oropharyngeal pain
7%
White blood cell count decreased
6%
Gastrooesophageal reflux disease
6%
Influenza like illness
6%
Hot flush
6%
Neck pain
6%
Pain in extremity
6%
Blood alkaline phosphatase increased
5%
Muscle spasms
5%
Sinusitis
5%
Combined Anemia and/or low hemoglobin
1%
General physical health deterioration
1%
Incarcerated hernia
1%
Intestinal obstruction
1%
Sepsis
1%
Muscular weakness
1%
Combined Thrombocytopenia and/or low platelets
1%
Osteoarthritis
1%
Gastrointestinal pain
1%
Pulmonary embolism
1%
Febrile neutropenia
1%
Pancytopenia
1%
Small intestinal obstruction
1%
Dehydration
1%
Combined Netropenia and/or low ANC
1%
Malignant melanoma
1%
Malignant neoplasm progression
1%
Myelodysplastic syndrome
1%
Seizure
1%
Acute kidney injury
1%
Renal failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Rucaparib 600 mg Tablets
Placebo Tablets

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (nal-IRI, leucovorin, fluorouracil, rucaparib)Experimental Treatment5 Interventions
PHASE Ia: Patients receive liposomal irinotecan IV over 90 minutes, leucovorin calcium IV, and fluorouracil IV over 46 hours on days 1 and 15. Patients also receive rucaparib PO BID on days 4-13 and 18-27. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity. PHASE Ib/II: Patients receive liposomal irinotecan IV over 90 minutes and fluorouracil IV over 46 hours on days 1 and 15. Patients also receive rucaparib PO BID on days 4-13 and 18-27. Cycles repeat every 28 days in the absence of disease progression or unaccepted toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Leucovorin Calcium
2011
Completed Phase 3
~12290
Fluorouracil
2014
Completed Phase 3
~11540
Irinotecan Sucrosofate
2021
Completed Phase 2
~10
Rucaparib
2016
Completed Phase 3
~1990

Find a Location

Who is running the clinical trial?

Academic and Community Cancer Research UnitedLead Sponsor
53 Previous Clinical Trials
5,118 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,628 Total Patients Enrolled
Tanios S Bekaii-SaabPrincipal InvestigatorAcademic and Community Cancer Research United

Media Library

Fluorouracil (Antimetabolite) Clinical Trial Eligibility Overview. Trial Name: NCT03337087 — Phase 1 & 2
Colorectal Cancer Research Study Groups: Treatment (nal-IRI, leucovorin, fluorouracil, rucaparib)
Colorectal Cancer Clinical Trial 2023: Fluorouracil Highlights & Side Effects. Trial Name: NCT03337087 — Phase 1 & 2
Fluorouracil (Antimetabolite) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03337087 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there other examples of Rucaparib being used in medical research?

"583 clinical trials are currently underway to study Rucaparib's efficacy. Of these, 159 are large-scale Phase 3 studies. Most research is based in Columbus, Ohio; however, there are 27913 total locations running some form of Rucaparib trial."

Answered by AI

What are some of the brand-name uses for Rucaparib?

"Rucaparib is most commonly used to treat small cell lung cancer, however it can also alleviate symptoms for other conditions like rectal carcinoma, colorectal carcinoma, and joint pain."

Answered by AI

Are people with the required medical conditions able to join this study at this time?

"Indeed, the trial is still ongoing and actively recruiting patients, as shown by its listing on clinicaltrials.gov. The study began recruitment on November 2nd, 2018 and the most recent update was June 1st, 2022. They are currently looking for 18 more participants at 4 different sites."

Answered by AI

How many people are sign-ups for this research project?

"In order for this study to move forward, 18 individuals that meet the pre-determined inclusion criteria must enroll. These patients can be based out of different locations such as Mayo Clinic in Rochester, Scottsdale, Arizona and Mayo Clinic in Arizona, Atlanta, Georgia."

Answered by AI

What primary goals does this research hope to accomplish?

"This study, which will be monitored over a period of 32 weeks, has the primary goal of achieving an objective response (Phase Ib). Secondary outcomes that will be used to assess the efficacy of the treatment include the incidence of adverse events (Phase II) as defined by the National Cancer Institute's Common Terminology Criteria for Adverse Events version 4.03, disease control rate (DCR) as defined by RECIST version 1.1, and overall survival (Phase II)."

Answered by AI
~3 spots leftby Mar 2025