Clinical trial · Interventional
Polyphenon E in Treating Patients With High-Risk of Colorectal Cancer
Randomized Phase II Trial of Polyphenon E vs.Placebo in Patients at High Risk of Recurrent Colonic Neoplasia
NCT01606124CI-TRIAL-00030109terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): pending expiration of the supply of study agent.
Summary
Brief summary (as posted)
This phase II trial studies how well Polyphenon E works in treating patients with high-risk of colorectal cancer. Polyphenon E contains ingredients that may prevent or slow colorectal cancer.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Colon | Colon Adenocarcinoma | ALIAS | 0.90 |
| Advanced Colorectal Adenomas | Colon Neoplasm | PROBABILISTIC | 0.70 |
| Stage I Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
| Stage III Colon Cancer | Malignant Colon Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| defined green tea catechin extract | Drug | — | UNRESOLVED |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I (Green Tea Catechin Extract)
- description
- Patients receive Polyphenon E PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Drug: defined green tea catechin extract
- Other: questionnaire administration
- Other: laboratory biomarker analysis
- type
- PLACEBO_COMPARATOR
- label
- Arm II (placebo)
- description
- Patients receive placebo PO BID. Courses repeat every 28 days for 6 months in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Other: placebo
- Other: questionnaire administration
- Other: laboratory biomarker analysis
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Current or prior advanced adenomas. Participants with advanced adenomas are defined as participants who have polyps \>= 1 cm, who have tubulovillous adenomas (25-75 percent villous features), who have villous adenomas (\>75 percent villous), or who have severe dysplasia * Prior curatively resected Tumor, Node, Metastasis (TNM) stage II and III colon cancer \>= 3 years out from treatment by surgery with/without adjuvant chemotherapy; NOTE: patients with stage I (T1,2 N0) colon cancer treated by endoscopic or surgical therapy are eligible at anytime after such therapy; patients with prior stage IV disease must be \>= 5 years status post surgical resection of all metastatic disease * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1 * Ability to understand and the willingness to sign a written informed consent document * Willingness to discontinue regular usage of calcium supplements; Exception: multi-vitamin; regular use defined as a frequency of 7 consecutive days for \> 3 weeks * Willingness to provide mandatory tissue and blood for protocol specified research; residual tissue and/or blood may be used for future research Negative pregnancy test =\< 7 days prior to registration/randomization * Hemoglobin (Hgb) \>= 12.0 g/dL (women), \>= 13.5 g/dL (men) at Mayo Clinic or within normal limits at an outside laboratory * Platelet count \>= 100,000/ul * White blood cells (WBC) \>= 3,000/ul * Alanine aminotransferase (ALT) within institutional limits of normal * Alkaline phosphatase within institutional upper limit of normal (ULN) * Aspartate aminotransferase (AST) within institutional limits of normal * Total bilirubin within institutional limits of normal * Serum calcium =\< institutional ULN * Serum creatinine =\< 1.5 x institutional ULN * \>= 5 rectal ACF detected by chromoendoscopy =\< 45 days prior to registration/randomization * Endoscopy =\< 45 days prior to registration/randomization; Note: All adenomas or polyps will be removed according to institutional standards of care, and the cecum must visualized; this may be done at the same time as the chromoendoscopy Exclusion Criteria: * Any history of rectal cancer; Exception: transanal excision without radiation * Known diagnosis of colon heritable cancer syndrome (Familial adenomatous polyposis \[FAP\], hereditary nonpolyposis colorectal cancer \[HNPCC\]) or inflammatory bowel disease (Crohn's disease, ulcerative colitis) * Inability to swallow capsules * Bleeding diathesis * Any invasive malignancy =\< 5 years prior to pre-registration; * Exceptions: * patients with nonmelanoma skin cancers that were treated with simple excisional biopsy or stage I (T1,2 N0) * colon cancer treated by endoscopic therapy or surgery are eligible * History of gastroduodenal ulcers documented =\< 1 year * Known inability to participate in the scheduled follow-up tests * Significant medical or psychiatric problems which would make the participant a poor protocol candidate, in the opinion of the treating physician * Total colectomy * Colostomy * History of pelvic or rectal radiation therapy * History of liver disease * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia * Concomitant corticosteroids or anticoagulants needed on a regular or predictable intermittent basis * Use of non-study investigational agent(s) =\< 3 months prior to preregistration * Chemotherapy =\< 6 months prior to pre-registration; Note: Topical chemotherapy will be assessed on a case-by-case basis * Any of the following: \* Pregnant women \* Nursing women \* Men or women of childbearing potential who are unwilling to employ adequate contraception Note: This study involves an investigational agent whose genotoxic, mutagenic, and teratogenic effects on the developing fetus and newborn are unknown * Over-the-counter green tea or green tea extract use =\< 6 weeks prior to pre-registration; consumption of over the counter green tea extracts or drinking of green tea is not permitted during the treatment portion of this trial * Regular use of nonsteroidal anti-inflammatory drugs (NSAIDs) =\< 6 weeks prior to pre-registration; regular use of NSAIDs is defined as a frequency of 7 consecutive days (1 week) for \> 3 weeks; participant must abstain from regular use of NSAIDs for the duration of the study; Exception: low dose aspirin (81 mg) for those participants who are chronic users of aspirin prior to the beginning of the study * Use of non-study investigational agents while on study
References
Publications (0)
Data not yet available
No reference posted for this study.