Clinical Trial Information

Protocol: Wake Forest WF-1806

SCHMEA WF-1806

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

1. Older adults (65 years or older) with either:
   1. Newly diagnosed metastatic CRC or.
   2. Newly recognized metastatic recurrence of CRC greater than 1 year from completion of treatment for non-metastatic CRC
2. Planning to undergo 1st line 5-FU based chemotherapy (as monotherapy, as 5 FU alone or capecitabine or in combination with oxaliplatin and/or irinotecan with or without biologics).
3. Estimated life expectancy more than 6 months.
4. Patient eligibility is not dependent on BMI or weight. Patients with a significant plus or minus 10% body weight change in the previous 12 months are eligible for this study.

Ineligibiltiy:

1. Patients enrolled in hospice.
2. Prior systemic chemotherapy for metastatic colorectal cancer (acceptable if adjuvant chemotherapy completed more than 12 months prior to disease recurrence).
3. Patients may not be receiving any other investigational agents.
4. No untreated brain metastases. Patients with treated brain metastases are eligible.

Clinical Trial Information

Protocol: Alliance – A221805

SCHEMA A221805

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

Eligibility:

1. Stage II-III colorectal cancer patients scheduled to receive oxaliplatin 510 mg/m2 (cumulative dose) over 12 weeks as a component of adjuvant FOLFOX treatment in which patients are scheduled to receive oxaliplatin 85 mg/m2 every 2 weeks for 12 weeks (i.e. 6 cycles) or adjuvant CAPOX treatment in which patients are scheduled to receive oxaliplatin 130 mg/m2 every 3 weeks for 12 weeks (i.e. 4 cycles).
2. No prior neurotoxic chemotherapy.
3. No pre-existing clinical or pre-clinical peripheral neuropathy from any cause.
4. Comorbid conditions are not eligible.
5. No concomitant use of other adjuvant pharmacologic interventions (e.g. gabapentin, pregabalin, venlafaxine) with known or hypothesized efficacy for peripheral neuropathy. Must be discontinued at least 7 days prior to start of protocol treatment.
6. No concomitant use of non-pharmacologic interventions (known or hypothesized) for CIPN (e.g. cryotherapy, acupuncture).
7. No anticipated or concurrent use of warfarin or heparin products while patients are receiving study drug.  No anticipated or concurrent use of any antidepressant or serotonin altering agent or other potent CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine) known to interact with duloxetine, due to concern regarding cumulative toxicity and potential drug interactions. Use of an MAOI or other antidepressant must be discontinued at least 14 days prior to start of protocol treatment.
8. Chronic concomitant treatment with drugs that are extensively metabolized by CYP2D6 and that have a narrow therapeutic index, including certain antidepressants, phenothaizines and type 1C antiarrhythmics should be approached with caution
9. Chronic concomitant treatment with strong CYP1A2 inhibitors should be avoided during this trial due to concern regarding cumulative toxicity and potential drug interactions.
10. Age 25 years or older. Duloxetine black box warnings indicate an increased risk of suicide in patients.
11. ECOG performance status 0-2.

Clinical Trial Information

PROTOCOL: SWOG-S0820

SCHEMA S0820

Please Note: Below is a brief description of eligibility, please contact GHCI research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Patients must have a history of Stage 0, I, II or III colon or rectal adenocarcinoma that has been treated per standard care with resection alone or in combination with radiation or chemotherapy. Adjuvant chemotherapy and RT treatment must have been completed at least 30 days prior to registration.
2. Patients with history of segmental resections are eligible (i.e. right colectomy, extended right colectomy, transverse colectomy, left
   colectomy, extended left colectomy, sigmoid colectomy, low anterior resection, abdominoperineal resection). The definition of resection does not include endomucosal resection (EMR). Patients that have received total proctocolectomy are ineligible. In addition to segmental resections, the following types of procedures are allowed: Polypectomy: For Tis (Stage 0) or pT1 patients only, resection may consist entirely of polypectomy (without completion of partial colectomy) if ALL of the following criteria are met:
   1. Single specimen, completely removed.
      • Clear margins
      • None of the following must be present:
      o Moderate or poor differentiation
      o Lymphovascular invasion
      o Perineural invasion
   2. Transanal excision is allowed for pT1 rectal cancer patients with well or moderately differentiated tumors.
3. Patients must be at least 18 years of age.
4. Patients must not have a known history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer, inflammatory bowel disease, biallelic mismatch repair deficiency syndrome (BMMRD), or constitutional mismatch repair deficiency syndrome (CMMRD).
5. Patients must have a Zubrod Performance Status of 0 – 1 .
6. Patients must not be expecting to receive radiation or additional chemotherapy.
7. Patients must not be receiving or plan to receive concomitant oral or intravenous corticosteroids on a regular basis, nonsteroidal antiinflammatory drugs (NSAIDs), nor anticoagulants on a regular or predictable intermittent basis. (NSAID use may not exceed 10 days per month.) Patients may receive daily aspirin for cardiovascular prophylaxis as long as ASA is ≤ 100 mg per day or ≤ two 325 mg tablets per week. Inhaled steroids (i.e. for asthma or related conditions) are allowed.

Clinical Trial Information

PROTOCOL: Alliance-A221602

SCHEMA A221602

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Diagnosis of malignant disease.
2. No prior history of chemotherapy for any malignancy.
3. Scheduled to receive IV HEC (either cisplatin-containing AST or ALT ≤3 x upper limit of normal (ULN) regimen or doxorubicin and cyclophosphamide.
4. No nausea or vomiting ≤24 hours prior to registration.
5. Age ≥18 years.
6. ECOG Performance Status 0, 1 or 2.
7. No radiotherapy within 7 days prior to registration or planned for one week after the current dose of chemotherapy.

Clinical Trial Information

PROTOCOL: Wake Forest-Wf97116

SCHEMA WF-97116

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Women ≥18 years old with history of invasive breast cancer.
2.  Must have completed at least 4 cycles of adjuvant/neo-adjuvant cytotoxic chemotherapy between 1 and 5 years prior to enrollment (Ongoing herceptin or other chronic HER 2 directed therapies are allowed).
3. Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study enrollment and plan to continue for the duration of the study (9 months).
4. Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted if the patient whose eligibility is being assessed has been on the medication for at least 12 weeks. The dose of this medication must be stable for at least 4 weeks prior to enrollment.
5. Patients who were previously on one of these psychotropic medications and have subsequently discontinued the drug must have been off the medication for at least 4 weeks prior to enrollment.
6. Patients who have been on a psychotropic medication for at least 12 weeks but have recently switched to a medicine in the same class (for example, switching from one SSRI antidepressant to a different SSRI antidepressant) need to be on a stable dose ofthe new medication for at least 4 weeks prior to enrollment to be eligible.
7. ECOG performance status 0-2.
8.  No evidence of or suspected recurrent or metastatic disease.
9.  No prior brain irradiation.
10.  No planned therapy (surgery, radiation, chemotherapy, or immunotherapy) while on the study for brain and/or extracranial primary/metastatic disease.

Clinical Trial Information

PROTOCOL: URCC-18007

SCHEMA URCC 18007

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Be female at least 18 years of age.
2. Been diagnosed with Stage I-III breast cancer.
3. Be currently breast cancer-free.
4. Report moderate to severe fatigue in the past week.
5. Attribute their fatigue to cancer and/or its treatment.
6. Have completed surgery, radiation, standard dose chemotherapy, and/or targeted therapy 12-60 months previously (participants can be receiving hormonal therapy – i.e., tamoxifen, anastrozole, letrozole, exemestane).
7. No other medical condition in which fatigue is a prominent symptom as documented in the medical chart (e.g., anemia, autoimmune disease, sleep apnea).
8.  Not be currently taking Bupropion, Wellbutrin, Forfivo, Aplenzin, or Zyban (i.e., bupropion prescribed
   for other indications); an anti-depressant including but not limited to an MAOI inhibitor, antipsychotic, a systemic anti-TNF agent, linezolid, methylene blue, or a systemic corticosteroid (patients who have previously completed treatment with these agents at least one week prior and meet all other eligibility criteria are eligible to participate). Participants should be off an MAOI for at least 2 weeks prior to study entry.

Clinical Trial Information

PROTOCOL: URCC-16070

SCHEMA URC 16070

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Have a diagnosis of breast cancer and be chemotherapy naïve. Note: Prior methotrexate for non-cancerous conditions is allowed.
2. Be scheduled to receive a single-day chemotherapy regimen that contains doxorubicin, and/or cyclophosphamide, and/or carboplatin. Herceptin® (trastuzumab) and other chemotherapy agents will be allowed with any of these regimens.
3. Be scheduled to receive an antiemetic regimen that does not contain Akynzeo®.
   1. • For chemotherapy regimens with a high emetic risk, the antiemetic regimen must include an NK-1 antagonist receptor, a 5HT3 receptor antagonist and dexamethasone. Other antiemetics, including additional dexamethasone and olanzapine, may also be included at cycle one.
   2. For chemotherapy regimens with a moderate emetic risk, the antiemetic regimen must include a 5HT3 receptor antagonist and dexamethasone. Other antiemetics, including additional dexamethasone and olanzapine, may also be included at cycle one.
4. Be female and at least 18 years of age.
5. Have ECOG performance status of 0, 1, or 2.

Clinical Trial Information

PROTOCOL: ECOG-EAZ171

SCHEMA EAZ171

Please Note: Below is a brief description of eligibility, please contact GHCI Research Department to discuss full eligibility requirements.

ELIGIBILITY:

1. Patients must be women with a known stage I-III invasive breast cancer diagnosis. Registration must occur within 84 days from the
   date of diagnosis.
2. Patients must be age ≥ 18 years.
3. Patients must have plans to receive either neoadjuvant or adjuvant:
   1. Every 3-week docetaxel x 4-6 cycles  OR
   2. Weekly paclitaxel x 4 cycles.
4. Patients must self-identify their race as black, African American, or of African descent. Patients may be of any ethnicity.
5. Patients must not have received prior taxane or prior/concurrent platinum therapy.
6. Patients must not have received neoadjuvant anti-HER2 therapy.
7. Patients with a history of other cancers are eligible if they have not received prior taxane or platinum or vinca alkaloid therapy.
8. ECOG Performance status 0-1.
9. Patients must not have pre-existing peripheral neuropathy.