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Pancreatic CancerPhase 2NCT01693523

Minocycline Study in Pancreatic Cancer Patients

A Phase 2 study testing Minocycline and Questionnaires in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this clinical research study is to learn if minocycline can reduce the side effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will be compared to a placebo. Minocycline is an antibiotic that may help to reduce side effects of chemotherapy. A placebo is not a drug. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pancreatic Cancer
What is being tested?
Minocycline and Questionnaires
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
80 participants
Where
1 siteUnited States
Study dates
28 Jan 2013to 19 Sep 2018
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Minocycline Trial only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX or gemcitabine-based chemotherapy.
  • Observational Arm only: Patients with a pathological or clinical diagnosis of pancreatic cancer and beginning or continuing FOLFIRINOX chemotherapy.
  • Patients > 18 years old.
  • Minocycline Trial only: Patients with ECOG PS = 0-2.
  • Patients who speak English or Spanish (due to MDASI language options, we are only accruing English-speaking or Spanish-speaking patients to the protocol).
  • Patients willing and able to review, understand, and provide written consent before starting therapy.
  • Minocycline Trial only: Patients with adequate renal function according to MD Anderson testing standards (screening cut off for serum creatinine < 2 times the upper limit of normal).
  • Minocycline Trial only: Patients with adequate hepatic function according to MD Anderson testing standards (screening results for total bilirubin must be < 2 times the upper limit of normal; screening results for alanine aminotransferase (ALT) must be < 3 times the upper limit of normal; screening results for aspartate aminotransferase (AST), if available, must be < 3 times the upper limit of normal).

Who cannot join

  • Minocycline Trial only: Patients who are taking medication or have conditions that potentially preclude use of minocycline, as determined by the treating physician.
  • Patients who are enrolled in other symptom management clinical trials.
  • Minocycline Trial only: Patients who currently have bile duct obstruction or cholelithiasis.
  • Minocycline Trial only: Patients with hypersensitivity to any tetracyclines.
  • Minocycline Trial only: 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.
  • Minocycline Trial only: Patients who are under treatment of warfarin with INR > 1.5.
  • Patients who, in the judgment of the investigator, may be unable to participate in the required study procedures.
  • Minocycline Trial only: Patients who have had prior treatment for pancreatic cancer within the past six months may be excluded at the discretion of the investigator.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

Official title: A Randomized, Placebo Controlled-Double Blind Study of Minocycline for Reducing the Symptom Burden for Pancreatic Cancer Patients

The goal of this clinical research study is to learn if minocycline can reduce the side effects of chemotherapy in patients with pancreatic cancer. In this study, minocycline will be compared to a placebo.

Minocycline is an antibiotic that may help to reduce side effects of chemotherapy.

A placebo is not a drug. It looks like the study drug, but it is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.

Read the detailed description

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.

You will begin taking the study drug/placebo on, or within 2 days of, Day 1 of the first chemotherapy cycle after you are enrolled on the study. You will take the study drug/placebo capsule by mouth, every day for up to 4 cycles (up to 8 weeks, if there are no treatment delays).

It is possible that your chemotherapy start may be delayed if it takes additional time for your central venous catheter (CVC) to be placed. A CVC is a sterile flexible tube that will be placed into a large vein while you are under local anesthesia. If this happens, you may choose to start taking the study drug/placebo up to 2 weeks before you start chemotherapy, instead of waiting to 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:

  • If you can become pregnant, blood (about 2 teaspoons) will be drawn for a pregnancy test. If the pregnancy test is positive, it will be repeated after 48 hours to make sure you are pregnant. Sometimes, cancer can cause a "false positive" on a pregnancy test.
  • 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.
  • If possible, 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 2 times each week during the first cycle and 1 time each week during any remaining cycles. The symptom questionnaire asks 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.
  • You will complete the questionnaires in paper-and-pencil format or on an electronic tablet PC if you are in the clinic. When you are away from the clinic you will complete the questionnaires on the telephone or on your computer.
  • If possible, during your clinic visits at the start of cycle 2, 3, and 4 (if applicable), 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 up to 8 weeks, if there is no delay in starting your chemotherapy cycles. You will take the study drug/placebo for up to 8 weeks. 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 the end of the last study cycle after you complete the symptom treatment, you will complete 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.

Being tested
Minocycline, Placebo, Questionnaires
Keywords
Pancreatic Cancer, Pancreatic adenocarcinoma, Locally advanced, Metastatic disease, Symptom reduction, Minocycline, Dynacin, Minocin, Minocin PAC, Myrac, Solodyn, Placebo, Sugar Pill, Questionnaires, Surveys
Medical subject headings
Pancreatic Neoplasms, Neoplasm Metastasis, cyclopia sequence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MinocyclineDrug

    Also called Dynacin, Minocin, Minocin PAC, Myrac

    100 mg by mouth two times a day (200 mg/day).

  • PlaceboOther

    Also called Sugar pill

    Matching placebo capsules by mouth twice a day.

  • QuestionnairesBehavioural

    Also called Surveys

    Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.

Study groups in NCT01693523
Study groupRoleWhat they receive
MinocyclineExperimentalMinocycline 100 mg by mouth two times a day (200 mg/day). Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Receives: Drug: Minocycline; Behavioral: Questionnaires
PlaceboPlacebo comparatorMatching placebo capsules by mouth twice a day. Initial Dose (starts on first day of run-in phase or chemotherapy). Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
Receives: Other: Placebo; Behavioral: Questionnaires

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms

    Each item is rated on a 0 to 10 scale with 0 = symptom not present or no interference and 10 meaning the symptom severity is as bad as can be imagine or complete interference using the MD Anderson Symptom Inventory (MDASI). It is a measure of symptom burden, which includes symptom severity and how they interfere with daily functioning. For this study, the sub scale is the average of the 5 pre-selected items namely fatigue, pain, disturbed sleep, lack of appetite and drowsiness. This subscale ranges from 0 to 10. The primary outcome is the average of the 70-day area (10 week study) under the curve for the sub scale. AUC ranges from 0 (0*70) to 700 (10*70). To put this into perspective, the average AUC for the placebo group of 200.8 can also be thought of as 2.87 (200.8/70) on a 0 to 10 scale over the 70 day study period. Lower values represent better outcome. Higher values represent worse outcome.

    Measured: AUC from baseline to 2 weeks

Secondary outcomes (1)

  1. Relationship Between Dynamic Changes in Inflammation Biomarkers and Symptom Outcomes, Controlling for the Grouping Variables (Tumor Markers, Weight Loss), Evidence of Infection, ECOG PS, Age and Gender Examined

    Measured: 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2012 (estimated)
  2. Study start28 Jan 2013
  3. Primary completion19 Sep 2018
  4. Study completion19 Sep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
80 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01693523
Sponsor's protocol ID
2012-0587
Other IDs
1R21CA158902-01A1, NCI-2012-02063
Status last verified
Feb 2020
First submitted
21 Sep 2012
Last updated
9 Mar 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Minocycline and Questionnaires in people with Pancreatic Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Area Under the Curve (AUC) of Apriori Selected MDASI Symptoms (time frame: AUC from baseline to 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01693523.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2020.

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