Stage IV Pancreatic Cancer
Conditions
Keywords
Pancreatic Neoplasms, Pancreatic Cancer cells, Digestive System Neoplasms, Neoplasms by Site, Neoplasms, Endocrine Gland Neoplasms, Digestive System Diseases, Pancreatic Diseases, Endocrine System Diseases, Ascorbic Acid, Gemcitabine Vitamins, Vitamin C, Antioxidants, Molecular Mechanisms of Pharmacological Action, Pharmacologic Actions, Protective Agents, Physiological Effects of Drugs, Micronutrients, Growth Substances, Erlotinib, Integrative Medicine, Alternative Medicine, Complementary Medicine
Brief summary
The investigators recently completed a phase I study of intravenous ascorbic acid (IV AA) plus standard chemotherapy (gemcitabine and erlotinib) in patients with metastatic pancreatic cancer. The investigators determined that the target ceiling dosage of 100 grams of ascorbic acid is safe when given with the chemotherapy. This Phase II trial is an initial test of efficacy of the 100 gram dose of ascorbic acid, which will be given with the same standard chemotherapy. This open label study will recruit up to 35 subjects with metastatic pancreatic cancer who will receive ascorbic acid combined with gemcitabine and erlotinib as front-line treatment. The phase I data suggests that ascorbic acid when given in combination with gemcitabine and erlotinib may result in some tumor response, and the goal of this study is to better evaluate the response and confirm initial safety data
Detailed description
Intravenous high dose ascorbic acid is a widely used alternative cancer treatment. Patients will receive standard care gemcitabine/erlotinib for treatment of their metastatic pancreatic adenocarcinoma. They will be closely monitored for disease response/ progression. If vitamin C has a beneficial effect on tumour cells, patients may experience a regression of tumor or tumor markers. Additional benefits include scans at no charge to the patient. This study requires several days of treatment per week and treatments are given in two different locations. The intravenous vitamin C treatments are given 3 times per week, these are given every week for an initial cycle of 15 weeks.
Interventions
DRUGAscorbic Acid
3x per week
Sponsors
Thomas Jefferson University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males and females of age ≥ 18 * Histologically or cytologically confirmed pancreatic adenocarcinoma that has metastatic disease measurable by CT, MRI, or PET * Subjects with unresectable pancreatic cancer who have had surgery (exploratory laparotomy, biliary, gastrointestinal bypass) are eligible, if the subject has fully recovered from surgery and ≥ 14 days has passed since the operation. Patients with history of pancreatoduodenectomy are eligible provided that there is radiographically documented disease recurrence. * ECOG performance status 0-2 * Laboratory values that would not prevent the patient from receiving chemotherapy as determined by the PI or study oncologist * G6PD status ≥ lower limit of normal * Serum creatinine ≤ 2.0 mg/dL
Exclusion criteria
* Islet cell or acinar cell carcinoma or cystadenocarcinoma * History or known presence of central nervous system (CNS) metastases * History of another primary cancer, except: * Curatively treated cervical carcinoma in situ, or * Curatively resected non-melanomatous skin cancer, or * Other primary solid tumor curatively treated with no known active disease present and no treatment administered for ≥ 3 years prior to enrollment * Other concurrent anticancer chemotherapy * Prior radiotherapy ≤ 14 days, or if subjects have not recovered from radiotherapy * Uncontrolled seizure disorder or other serious neurological diseases * Any co-morbid disease that would increase risk of toxicity as determined by PI * Only locally advanced disease * Prior treatment with gemcitabine (for metastatic pancreatic cancer) * Subjects requiring chronic use of immunosuppressive agents (eg, methotrexate, cyclosporine, corticosteroids) * Recent infection requiring a course of systemic anti-infection that was completed ≤ 14 days prior to enrollment (exception can be made at the judgment of the PI for oral treatment of an uncomplicated urinary tract infection (\[UTI\]) * History of any medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the PI, may increase the risks associated with study participation or study drug administration or may interfere with the conduct of the study or interpretation of study requirements * Subject unwilling or unable to comply with study requirements * Subject who is pregnant or breast feeding * Known positive test(s) for human immunodeficiency virus infection, hepatitis C virus, chronic active hepatitis B infection * Documented history of alcohol, cocaine or intravenous drug abuse ≤ 6 months of enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer | 15 weeks | Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument | 15 weeks | 1\) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ascorbic Acid, Gemcitabine & Erlotinib Ascorbic Acid (50-100g, 3x weekly) Standard Chemotherapy of Gemcitabine and Erlotinib for Pancreatic Cancer
Ascorbic Acid: 3x per week | 11 |
| Total | 11 |
Baseline characteristics
| Characteristic | Ascorbic Acid, Gemcitabine & Erlotinib |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 5 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 10 Participants |
| Region of Enrollment United States | 11 participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 11 |
| other Total, other adverse events | 11 / 11 |
| serious Total, serious adverse events | 1 / 11 |
Outcome results
Primary
Safety of Ascorbic Acid in Combination With Gemcitabine and Erlotinib for Stage IV Pancreatic Cancer
Safety: to assess safety of IVAA in combination with gemcitabine and erlotinib by evaluating the number of adverse events and serious adverse events occurring among study participants.
Time frame: 15 weeks
Population: The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.
Secondary
Evaluate Quality of Life Using Functional Assessment of Cancer Therapy-General (FACT-G) Quality Assessment Instrument
1\) To evaluate quality of life using Functional Assessment of Cancer Therapy-General (FACT-G) quality assessment instrument. The FACT-G questionnaire as well as the Patient Reported Outcomes Measurement Information System (PROMIS-29) will be used to assess quality-of-life longitudinally. Quality-of-life scores obtained from the FACT-G and PROMIS-29 will be summarized at multiple time points using means and standard deviations.
Time frame: 15 weeks
Population: The trial was closed due to lack of accrual. The standard of care treatment that was part of the study as initially written changed to a different chemotherapy regimen thus not enabling the team to enroll additional patients. The data were not collected.