Minocycline Study in Pancreatic Cancer Patients

NCT01693523 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 2012-05871R21CA158902-01A1NCI-2012-02063
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pancreatic Cancer

Keywords

Pancreatic Cancer; Pancreatic adenocarcinoma; Locally advanced; Metastatic disease; Symptom reduction; Minocycline; Dynacin; Minocin; Minocin PAC; Myrac; Solodyn; Placebo; Sugar Pill; Questionnaires; Surveys

Outcome Measures

Primary Outcomes (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.

  AUC from baseline to 2 weeks

Secondary Outcomes (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

  3 weeks

Study Arms (2)

Minocycline

EXPERIMENTAL

Minocycline 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.

Drug: Minocycline; Behavioral: Questionnaires

Placebo

PLACEBO COMPARATOR

Matching 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.

Other: Placebo; Behavioral: Questionnaires

Interventions

Minocycline DRUG

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

Also known as: Dynacin, Minocin, Minocin PAC, Myrac, Solodyn

Minocycline

Placebo OTHER

Matching placebo capsules by mouth twice a day.

Also known as: Sugar pill

Placebo

Questionnaires BEHAVIORAL

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

Also known as: Surveys

Minocycline; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Pancreatic Neoplasms; Neoplasm Metastasis; cyclopia sequence

Interventions

Minocycline; Sugars; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Dr. David Fogelman/ Associate Professor, GI Medical Oncology
• Organization: UT MD Anderson Cancer Center

dfogelman@mdanderson.org

832-710-7754

Study Officials

• David Fogelman, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

• Shelley Wang, MD,MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2012
• First Posted: September 26, 2012
• Study Start: January 28, 2013
• Primary Completion: September 19, 2018
• Study Completion: September 19, 2018
• Last Updated: March 9, 2020
• Results First Posted: February 19, 2020

Record last verified: 2020-02

Locations

US (1)