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Chemotherapy + Rucaparib for Digestive System Cancers
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2022 Phase 3 trial • 564 Patients • NCT01968213Trial Design
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Who is running the clinical trial?
Media Library
- I cannot swallow.I have not taken PARPi treatments recently, or it's been over a year since my last dose.I have gastroesophageal cancer and received only one prior treatment for it in the metastatic stage.I have biliary tract cancer with one prior treatment in the metastatic stage and no recent irinotecan.I have pancreatic cancer and have had only one prior treatment for it in the metastatic stage.My liver enzyme levels are within the required range for my condition.You agree to give tissue and blood samples for research purposes.I have pancreatic cancer with metastasis and received 2 or fewer treatments.I have biliary tract cancer with metastasis and received only one prior treatment.I have pancreatic cancer and have had only one prior treatment for it in the advanced stage.My liver enzyme levels are within the required range for my condition.I have taken a pregnancy test within the last week and it was negative.I am currently using a progesterone-only contraceptive like Depo Provera, Implanon, or Nexplanon.I stopped my previous chemotherapy more than 28 days ago.I am not on any experimental drugs for my cancer.I haven't had a different cancer in the last 3 years, except for certain skin, cervical, or superficial bladder cancers.I have not had irinotecan for metastatic cancer, except possibly as a colon cancer patient in early trials or as a pancreas cancer patient without recent worsening.I took irinotecan for cancer but didn't get worse within 3 months after the last dose.I have pancreatic cancer with specific genetic markers and haven't had treatment for it in its advanced stage.I am fully active or restricted in physically strenuous activity but can do light work.I have a certain type of cancer and have had no more than 2 treatments for it after it spread.I have colorectal cancer that has spread, and I've had up to 3 treatments for it.I have pancreatic cancer with specific genetic markers and haven't had treatment for it in its advanced stage.My kidney function, measured by creatinine or clearance, is within the required range.I am using or willing to use effective birth control or practice abstinence.I am currently breastfeeding.I am immunocompromised or HIV positive and on antiretroviral therapy.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.I am fully active or restricted in physically strenuous activity but can do light work.I have gastroesophageal cancer and received only one prior treatment for it in the metastatic stage.I have colorectal cancer that has spread, and I've had 3 or fewer treatments for it.I stopped my previous chemotherapy more than 28 days ago.I have a confirmed diagnosis of pancreatic, colorectal, gastroesophageal, or biliary cancer.My fallopian tubes are surgically blocked.My kidney function, measured by creatinine or clearance, is within the required range.My cancer can be measured by tests.I took irinotecan for cancer treatment and did not worsen within 3 months after the last dose.
- Group 1: Treatment (nal-IRI, leucovorin, fluorouracil, rucaparib)
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
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."
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."
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."
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."
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)."
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