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Chemotherapy for Pancreatic Cancer
Study Summary
This trial is studying gemcitabine hydrochloride given with or without erlotinib hydrochloride, followed by the same chemotherapy regimen with or without radiation therapy and capecitabine or fluorouracil, to see how well it works in treating patients with pancreatic cancer that has been removed by surgery.
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.Trial Design
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Who is running the clinical trial?
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- I have had surgery to remove all or part of my pancreas.I have not had chemotherapy for my pancreatic cancer unless it was one of the specified drugs.I've had radiation in the same area as my current cancer.My surgical margins are unclear after consulting with my surgeon and pathologist.I had surgery for pancreatic cancer that aimed to remove the tumor completely.My surgery was 21-70 days ago, and I haven't started chemotherapy yet or it was 21-77 days if I've had up to 3 months of chemo.I am 18 years old or older.I have been cancer-free for 2 years, except for non-melanoma skin cancer or carcinoma in situ.I haven't been hospitalized for heart issues like unstable angina or heart failure in the last 6 months.Your bilirubin levels are not more than two times the normal limit.My creatinine levels are within the normal range for the last 3 weeks.My liver enzyme SGOT levels are within the normal range.I've had the required scans or x-rays for my abdomen, pelvis, and chest within the last 31 days.My surgery report confirms the entire tumor was removed and details on the edges and size of the tumor.I am fully active or restricted in physically strenuous activity but can do light work.You had a blood test within the last 21 days.I have HIV with a CD4 count over 499 and a viral load under 50, and I may be on HAART.You have enough white blood cells called neutrophils in your body.You need to have at least 100,000 platelets per cubic millimeter of blood.My CA19-9 levels are 180 units/mL or lower before starting any treatment.I had a severe heart attack in the last 3 months.I am currently on IV antibiotics for a bacterial or fungal infection.I do not have a severe lung condition that requires hospital care right now.A radiation oncologist has approved me for radiotherapy according to the protocol.My hemoglobin level is at least 8.0 g/dL.I can eat enough (>= 1500 calories/day) without feeling very nauseous or vomiting.I've had a full check-up, including weight and general health status, within the last month.I do not have any severe, active health problems.Women who could become pregnant must have a negative pregnancy test within 14 days before joining the study.My cancer is not one of the excluded types like neuroendocrine or IPMN with minor invasive parts.My cancer is in an early to mid-stage, without distant spread.I am not using, or willing to use, birth control and I could have children.
- Group 1: Arm I (gemcitabine hydrochloride or combination chemotherapy)
- Group 2: Arm IV (chemotherapy, chemoradiotherapy)
- Group 3: Arm II (gemcitabine hydrochloride, erlotinib hydrochloride)
- Group 4: Arm III (chemotherapy)
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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
What are some of the short- and long-term risks associated with Chemotherapy?
"Chemotherapy was given a safety rating of 3 by our analysts at Power. This is because Phase 3 trials have shown some efficacy and there is a wealth of safety data available."
What are the most common purposes of Chemotherapy?
"Chemotherapy is most often used to treat actinic keratosis, but can also be useful in the treatment of colorectal carcinoma, malignant neoplasm of pancreas, and duke's c colon cancer."
Has Chemotherapy been looked at in other research projects?
"There are currently 1064 clinical trials underway that are studying chemotherapy. Of those, 330 are in Phase 3. Although many of the trials for chemotherapy are based in Guangzhou, Guangdong, there are 49933 locations running studies for this treatment."
Are there still open slots for new participants in this experiment?
"This particular study has completed recruitment for patients and is no longer enrolling. The study began on November 17th, 2009 and was last updated on September 23rd, 2022. For patients searching for other opportunities, there are 1,304 trials actively enrolling patients with pancreatic carcinoma and 1,064 studies for Chemotherapy actively enrolling patients."
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