A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients
18 Years
N/A
Both
Pancreatic Cancer
Trial Information
A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients
Study Groups:
If you agree to take part in this study, you will be randomly assigned (as in the flip of a
coin) to 1 of 2 groups. You will have an equal chance of being in either group:
- If you are in Group 1, you will take minocycline.
- If you are in Group 2, you will take a placebo.
Neither you nor the study staff will know if you are receiving the study drug or the
placebo. However, if needed for your safety, the study staff will be able to find out what
you are receiving.
Study Drug Administration:
Each study cycle is about 2 weeks.
Starting on Day 1 of Cycle 1, you may start taking the study drug/placebo capsule by mouth,
every day for up to 3-4 cycles (or about 6-8 weeks, if there are no treatment delays).
Your chemotherapy may be scheduled to start on the same day, or it may be delayed if it
takes longer for you to have your central venous catheter (CVC) placed. A CVC is a sterile
flexible tube that will be placed into a large vein while you are under local anesthesia.
If your chemotherapy cannot start on Day 1, you may choose to start taking the study
drug/placebo for up to 2 weeks before you start chemotherapy. You may instead choose to
wait and start taking it on the same day your chemotherapy begins. You can discuss these
options with the study doctor.
You should take the study drug/placebo dissolved in a full glass (8 ounces) of water. You
may take it with or without food, but if it causes an upset stomach, you should take it with
food.
If you have trouble swallowing the dose of study drug/placebo, you can open the capsule
right before you take it. You should not lie down for at least 30 minutes after taking the
study drug/placebo to reduce the risk of side effects.
You must bring the study drug/placebo container (along with any remaining drug/placebo) to
every study visit.
Study Visits:
Before you start your treatment with the study drug/placebo:
- You will complete 2 questionnaires about pain and other symptoms, and your quality of
life. It should take about 5-8 minutes to complete all of the questionnaires.
- Blood (about 2 tablespoons) will be drawn to test for markers of inflammation. Markers
of inflammation are found in the blood and may be related to your symptom development.
- Your demographic information, such as your marital status, job status, education, and
race will be recorded.
Before you start your chemotherapy treatment:
-If possible, blood (about 2 teaspoons) may be drawn to test for markers of inflammation,
only if you started treatment with the study drug/placebo while you waited for your CVC to
be placed for chemotherapy. If you choose to wait to start the study drug/placebo until
chemotherapy begins, this blood sample will not be drawn.
During treatment with the study drug/placebo:
- You will complete the symptom questionnaire in the clinic or by telephone 1 time each
week about any symptoms you may be having and how they may be affecting your daily
activities. You will also complete the quality of life questionnaire. The
questionnaires should take about 3-5 minutes to complete each time.
- If possible, during your clinic visits at the start of Cycle 3 and at the end of Cycle
3 or Cycle 4 of your chemotherapy (depending on whether you are having 3 or 4 cycles of
chemotherapy), blood (about 2 tablespoons) may be drawn to test for markers of
inflammation.
At the end of study drug/placebo treatment:
When you have finished taking the study drug/placebo, the study staff will contact you to
complete a questionnaire asking you about your opinions of the study drug/placebo. This
questionnaire will take about 3-5 minutes to complete.
Length of Study Participation:
You will be on study for 12 to 14 weeks, if there is no delay in starting your chemotherapy
cycles. You will take the study drug/placebo for 6 to 10 weeks and continue to complete the
questionnaires for 4-6 weeks after you have completed the study treatment. You will be
taken off study early if the disease gets worse, you have intolerable side effects, if you
are unable to follow study directions, or the study doctor thinks it is in your best
interest.
End-of-Study Visit:
At your first scheduled visit after you complete the symptom treatment, you will fill out
questionnaires about pain and other symptoms and your quality of life. It should take
about 3-5 minutes to complete the questionnaires. If possible, blood (about 2 tablespoons)
may be drawn to test for markers of inflammation.
Follow-Up:
The study staff will call you 30 days after you finish taking the study drug/placebo to ask
about any side effects you may be having. This call should last about 5 minutes.
This is an investigational study. Minocycline is FDA approved and commercially available
for the treatment of bacterial infection. Using minocycline to try to reduce the side
effects of chemotherapy in patients with pancreatic cancer is investigational.
Up to 76 patients will take part in this study. All will be enrolled at MD Anderson.
Inclusion Criteria:
1. Patients with a pathological diagnosis of pancreatic cancer, either locally advanced
or metastatic disease, and consented to receive FOLFIRINOX or Gemcitabine-based
chemotherapy at MD Anderson.
2. Patients > 18 years old
3. ECOG PS 0-2
4. Patients who speak English or Spanish (due to MDASI language options, we are only
accruing English-speaking or Spanish-speaking patients to the protocol)
5. Patients willing and able to review, understand, and provide written consent before
starting therapy
6. Patients with normal renal function according to MD Anderson testing standards and no
prior renal disease [screening cut off for serum creatinine < 2 times the upper limit
of normal]
7. Patients with normal hepatic function according to MD Anderson testing standards and
no prior liver disease [screening results for total bilirubin must be < 2 times the
upper limit of normal; screening results for the following must be < 3 times the
upper limit of normal for patients to be eligible: alkaline phosphatase (ALP) and
alanine aminotransferase (ALT). The screening results for aspartate aminotransferase
(AST) must be < 3 times the upper limit of normal if available.]
Exclusion Criteria:
1. Patients who are taking medication or have conditions that potentially preclude use
of minocycline, as determined by the treating physician
2. Patients who are enrolled in other symptom management clinical trials
3. Patients who currently have bile duct obstruction or cholelithiasis
4. Patients with hypersensitivity to any tetracyclines
5. Patients who are pregnant. Pregnancy will be confirmed by negative urine test;
patients with a positive urine test will be retested for doubling of HCG 48 hours
after the first test, because of beta-HCG's role as a tumor marker. Patients without
such a rise will be eligible for the study and will be enrolled at the investigator's
discretion.
6. Patients who are under treatment of warfarin with INR > 1.5
7. Patients who, in the judgement of the investigator, may be unable to participate in
the required study procedures
8. Patients who have had prior treatment for metastatic or locally advanced disease
within the past six months may be excluded at the discretion of the investigator.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Outcome Measure:
Symptom Reduction During FOLFIRINOX Chemotherapy
Outcome Description:
Primary outcome variable for the study is area under the curve (AUC) value of 5 symptoms: fatigue, drowsiness, pain, disturbed sleep, and lack of appetite over 6 weeks. Estimates of treatment effect obtained using standard linear regression techniques in which AUC values are regressed on indicator variables that represent treatment received. AUC is calculated using a trapezoidal approximation. Area of trapezoid is derived by multiplying half of base with sum of two heights. Base is number of days in between two administration of M.D. Anderson Symptom Inventory (MDASI). Two heights correspond to two mean symptom scores computed at each of these assessments. AUC is measured in units of mean MDASI score in days. Area for subsequent trapezoid calculated in same way. AUC is sum of area of 6 trapezoids.
Outcome Time Frame:
6 weeks
Safety Issue:
No
Principal Investigator
David Fogelman, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2012-0587
NCT ID:
NCT01693523
Start Date:
January 2013
Completion Date:
Related Keywords:
- Pancreatic Cancer
- Pancreatic Cancer
- Pancreatic adenocarcinoma
- Locally advanced
- Metastatic disease
- Symptom reduction
- Minocycline
- Dynacin
- Minocin
- Minocin PAC
- Myrac
- Solodyn
- Placebo
- Sugar Pill
- Questionnaires
- Surveys
- Pancreatic Neoplasms
Name | Location |
|---|---|
| University of Texas MD Anderson Cancer Center | Houston, Texas 77030 |
