A Phase 1/2 interventional study of Ascorbic Acid and Irinotecan in Stage IV Colorectal Cancer, sponsored by Thomas Jefferson University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-06.
Sponsored by Thomas Jefferson University · Phase 1/2, Interventional, and Treatment
This protocol is a phase I/II, study of ascorbic acid (AA) infusions combined with treatment with irinotecan versus treatment with irinotecan alone in patients with recurrent or advanced colorectal cancer who have failed at least one treatment regimen with a 5-FU based therapy. This study will be conducted as an amendment to Investigational New Drug # 77486.
Phase I: To assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated. This aim will be assessed by enrolling a minimum of 6 subjects meeting inclusion criteria, using a modified 3+3 design. Safety will be assessed with the following: toxicity graded by the NCI CTC, urinalysis pre- and post-infusion, basic metabolic panel, and CBC. From our experience and in the experience of our study collaborators, we hypothesize that the combination of IV AA with irinotecan will not be associated with adverse events.
Phase II: To utilize CT or PET/CT (when available) scans to evaluate disease progression to assess overall tumor response rate (complete and partial response) in subjects with advanced or recurrent colorectal cancer treated with the combination of ascorbic acid and irinotecan versus irinotecan alone.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's enrollment of 4 is below the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Thomas Jefferson University is the lead sponsor of 384 studies on the registry; 71 are open to participants now.
Of its 44 completed or terminated interventional studies of FDA-regulated products, 20 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Ascorbic Acid (50-100g, 3x weekly) with 350mg/m2 irinotecan once a week every 3 weeks
Drug: Ascorbic Acid · Drug: Irinotecan
350mg/m2 irinotecan once a week every 3 weeks
Drug: Irinotecan
3x a week for 9 weeks
Also known as: Ascorbate, Vitamin C
350mg/m2 once a week every 3 weeks
Also known as: Camptothecin-11, CPT-11
Number of Participants That Experience Serious Adverse Events as Defined by the Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
Time frame: 9 weeks +/- 2 weeks
Number of Participants That Are Alive After 11 Weeks.
To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer
Time frame: 9 weeks +/- 2 weeks
| Milestone | Ascorbic Acid | Standard of Care (Irinotecan Alone) |
|---|---|---|
| Started | 4 | 0 |
| Completed | 4 | 0 |
| Not completed | 0 | 0 |
Safety: The primary aim is to assess whether or not (IV) Ascorbic Acid (AA) with irinotecan therapy is relatively safe and well-tolerated according to Common Terminology Criteria for Adverse Events (CTCAE) v4.0.
No measurements were reported for this outcome.
To evaluate progression-free survival related to treatment of patients with advanced or recurrent colorectal cancer
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ascorbic Acid+Irinotecan | 0/4 (0%) | 0/4 (0%) | 2/4 (50%) |
| Standard of Care (Irinotecan Alone) | — | — | — |
| Event | Ascorbic Acid+Irinotecan | Standard of Care (Irinotecan Alone) |
|---|---|---|
| HypokalemiaBlood and lymphatic system disorders | 1/4 | — |
| Low HemoglobinBlood and lymphatic system disorders | 1/4 | — |
The Phase 2 portion of this study never enrolled and therefore no patients were enrolled to the standard of care arm.
| Age, Categorical(Participants) | Ascorbic Acid+Irinotecan | Standard of Care (Irinotecan Alone) | Total |
|---|---|---|---|
| <=18 years | 0 | — | 0 |
| Between 18 and 65 years | 1 | — | 1 |
| >=65 years | 3 | — | 3 |
| Sex: Female, Male(Participants) | Ascorbic Acid+Irinotecan | Standard of Care (Irinotecan Alone) | Total |
|---|---|---|---|
| Female | 3 | — | 3 |
| Male | 1 | — | 1 |
| Ethnicity (NIH/OMB)(Participants) | Ascorbic Acid+Irinotecan | Standard of Care (Irinotecan Alone) | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | — | 0 |
| Not Hispanic or Latino | 4 | — | 4 |
| Unknown or Not Reported | 0 | — | 0 |
| Race (NIH/OMB)(Participants) | Ascorbic Acid+Irinotecan | Standard of Care (Irinotecan Alone) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 |
| Asian | 0 | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 |
| Black or African American | 2 | — | 2 |
| White | 1 | — | 1 |
| More than one race | 0 | — | 0 |
| Unknown or Not Reported | 1 | — | 1 |
| Region of Enrollment(participants) | Ascorbic Acid+Irinotecan | Standard of Care (Irinotecan Alone) | Total |
|---|---|---|---|
| United States | 4 | — | 4 |
Plan to share: No
This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Thomas Jefferson University