Cancer Research Program – Spring 2018

Active Protocols by Disease Site

Research Investigators

Stuart Krauss, MD, Med Oncology
May Hashimi, MD, Med Oncology

Cancer Research Nurse

Perla Mota, RN
Phone: 773-564-5032

Regulatory Affairs

Amanda Clark
Phone: 708 -763-2719

Breast

Prevention
A011401
Breast Cancer Weight Loss Study (BWEL Study) Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer NCT02750826

 

  • BMI > 27kg/m2 documented within 56 days prior to registration. Most recent BMI must be used for eligibility
  • Histologically confirmed invasive breast cancer and registration must occur within 12 months after the first diagnosis
  • No history of invasive breast cancer in 5 years prior to registration other than the current diagnosis (prior DCIS at any time is acceptable)
  • Patients must have had a bilateral mammogram within 12 months prior to registration unless the initial surgery was a total mastectomy
  • All adjuvant or neoadjuvant chemotherapy, radiation, and surgery completed at least 21 days prior to registration
  • Surgical margins must be clear of invasive carcinoma
  • All subjects must have sentinel lymph node biopsy and/or axillary lymph node dissection
  • Must meet comorbid conditions of the protocol
  • ECOG status 0 or 1 BMI between 18 and 35 kg/m

Quality of Life
E1Z11
A Cohort Study to Evaluate Genetic Predictors for Aromatase Inhibitor Musculoskeletal Symptoms (AIMSS) NCT01824836

  • Must have ER + and/or PR + histologically confirmed Stage I-III adenocarcinoma of the breast
  • Must be female and post-menopausal
  • Must have completed recommended local therapy & adjuvant chemo
  • Must not have received prior AI therapy with exemestane, letrozole, or anastrozole as adjuvant therapy or for prevention of breast cancer. Prior tamoxifen as adjuvant therapy or for prevention is allowed.
  • Plan to treat with anastrozole for at least 12 month
  • PS0-2
  • Must not be currently taking (or have taken in the past 6 months) ongoing, daily analgesic medication for active, chronic conditions (Note: pts taking daily low dose aspirin are allowed to participate
  • Must have worst pain rated as < 4 out of 10 within one week prior to

Adjuvant
A011502
Phase II Double-Blinded Placebo-Controlled Trial of Aspirin as Adjuvant Therapy for Node-Positive HER2 Negative Breast Cancer: The ABC Trial NCT02927249

  • The patient can be male or female, with an ER/PgR status
  • Regular NSAID/aspirin use (defined as > 5 days per week) if stopped one year prior to study entry
  • Patient must be enrolled within 1 year of diagnosis
  • PS 0-2
  • No history of GI Bleeding requiring transfusion, stroke, MI, afib, or chronic use of oral steroids
  • No prior malignancy of any type within the past 5 years other than breast cancer, basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix

NRG-BR003
A Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or without Carboplatin for Node-Positive or High-Risk Node-Negative Triple-Negative Invasive Breast Cancer NCT02488967

  • The tumor must be unilateral invasive adenocarcinoma of the breast on the histological exam
  • The tumor must have been determined to be HER2-negative based on study parameters
  • The tumor must have been determined to be ER– and PgR Negative assessed by current ASCO/CAP guidelines. Patients with < 1% ER and PgR staining by IHC are considered negative
  • The patient must have undergone either a mastectomy or lumpectomy

S1207
SWOG
Stage II-III
Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of EVEROLIMUS in Patients with High-Risk, Hormone Receptor-Positive, and HER2/neu Negative Breast Cancer NCT01674140

  • Histologically confirmed invasive breast carcinoma
  • ER + and/or PR +; Her-2 negative
  • PS 0-2
  • Multifocal, multicentric, synchronous bilateral, and primary inflammatory breast cancers are allowed
  • Completion of adjuvant chemotherapy and pathologically negative lymph nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® Recurrence Score > 25 (completed as SOC)
  • Completion of adjuvant chemotherapy, and pathologically 1-3 positive lymph nodes, and an Oncotype DX® Recurrence Score > 25
  • Completion of adjuvant chemotherapy and pathologically 4 or more positive lymph nodes independent of the Oncotype DX® Recurrence Score in the primary tumor
  • Completion of neoadjuvant chemotherapy and > 4 positive nodes pathologically determined prior to or after chemotherapy
  • Patients who had breast-conserving surgery must have completed whole breast radiation; Pts with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal basin radiation therapy
  • Must have undergone axillary staging by sentinel node biopsy or axillary lymph node dissection (ALND).
  • Must have completed standard neoadjuvant or adjuvant taxane and/or anthracycline-based chemotherapy prior to randomization.
  • May have started endocrine therapy at any time after the diagnosis of the current breast cancer.

S1418/BR006
Phase III Randomized Trial to Evaluate the Efficacy Stage II-III And Safety of MK-3475 as Adjuvant Therapy for Triple Receptor-Negative Breast Cancer with > 1cm Residual Invasive Cancer or Positive Lymph Nodes After Neoadjuvant Chemotherapy NCT029554874

  • Patients must have histologically confirmed ER-, PR-, and HER2 equivocal status and must not have received and not be planning to receive adjuvant anti-HER2 or endocrine therapies after completion of neoadjuvant chemotherapy
  • Must not have metastatic or locally recurrent disease
  • Patients must have completed their final breast surgery (rendering them free from disease) with clear resection margins for invasive cancer and DCIS within the following timelines
  • 90 days prior to screening registration for patients not receiving postoperative (adjuvant) chemotherapy OR
  • 270 days prior to screening registration for patients who have received post-operative adjuvant therapy
  • Must not have had prior immunotherapy with anti– PD-L1, anti-PD1, anti-CTLA4, or similar drugs
  • Patients must not be planning to receive concomitantly other biologic therapy, hormonal therapy, other chemotherapy, surgery, or other anti-cancer therapy except radiation while receiving treatment in this study
  • Patients must not have a history of non-infectious pneumonitis that required steroids or active pneumonitis
  • Patients must have Zubrod Performance > 2
  • No other invasive malignancy is allowed except for the following; adequately treated skin cancer, in-situ breast or cervical cancer, Stage I or II invasive cancer treated with curative intent without evidence of disease recurrence for at least 5 years

Locally Advanced/Metastatic
E2112
A Randomized Phase III Trial of Endocrine Therapy plus Entinostat/Placebo in Patients with Hormone Receptor-Positive Advanced Breast Cancer NCT02115282

  • Estrogen receptor (ER) and/or progesterone receptor (PR) positive histologically confirmed adenocarcinoma of the breast with staining of > 1% cells will be considered positive.
  • Patients whose tumors have HER2 IHC+, ISH > 2.0 or average HER2 copy number > 6.0 signals per ell are not eligible.
  • Patients must have measurable or non-measurable Stage III/ locally advanced metastatic carcinoma of the breast, where local therapy with curative intent is not possible.
  • Pre/peri– and postmenopausal women and all men are eligible
  • Patients must not have known central nervous system metastasis or a history of DNS metastases
  • Patients may have received one prior chemotherapy regimen for metastatic disease provided treatment was completed > 3 weeks prior to randomization

Colon/Rectal

Prevention
S0820
SWOG
Stage 0-IIIA Double-Blind Placebo-Controlled Trial of Eflornithine andSuldinac to Prevent Recurrence of High-Risk Adenomas and Stage 0-III Second Primary Colorectal Cancers in Patients with Colon or Rectal Cancer Phase III-Preventing Adenomas of the Colon with PACES NCT01349881

  • No synchronous contralateral breast cancer
  • History of Stage 0, I, II or III colon cancer with primary resection one year previously
  • Patients with rectosigmoid cancer eligible if no radiation therapy
  • One year post-op colonoscopy and CT scans of chest abdomen & pelvis showing no evidence of disease
  • At least 30 days from completion of adj chemo
  • PS 0-1
  • Must have a pure tone audiometry evaluation to document air conduction within 30 days prior to registration. No > 20dB uncorrectable hearing loss for an age of any two continuous frequencies.
  • Must not have documented hx of gastric/duodenal ulcer within 12 months

Multiple Myeloma

Adjuvant
E1A11
Weiss/WSMC
Randomized Phase III Trial of Bortezomib, Lenalidomide and ECOG Dexamethasone (VRd) Versus Carfilzomib, Lenalidomide and Dexamethasone (CRd) Followed by Limited or Indefinite Duration Lenalidomide Maintenance in Patients with Newly Diagnosed Symptomatic Multiple Myeloma (ENDURANCE) NCT01863550

  • Must be diagnosed with symptomatic standard-risk multiple myeloma (SR-MM) within 90 days prior to registration as defined by the protocol.
  • Patients must have the measurable or evaluable disease as defined by having one or more the following, within 28 days prior to randomization;
    > 1 g/dl monoclonal protein (M-protein) or serum protein electrophoresis
    o 200 mg/24 hrs of monoclonal protein on a 24-hour urine protein electrophoresis
    o Involved free light chain > 10 g/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio (<0.26 or>1.65)
    o Monoclonal bone marrow plasmacytosis > 30% (evaluable disease)
    o Patients must have received no more than one cycle of prior chemotherapy and no more than 160 mg of prior dexamethasone (or equivalent dose of prednisone) for treatment of symptomatic myeloma.
    o No prior exposure to thalidomide, bortezomib, or carfilzomib for treatment of symptomatic myeloma

Multiple Sites

Prevention
2018-035
Prevalence of Cancer Survivors’ Use of Recommended Dietary Guidelines, as one of Several Lifestyle Choices, That May Aid in Reducing Their Risk of Cancer, and Prevalence of Participants’ Intentions to Alter Dietary Choices After Education

  • Must be over 18 years old and able to read, write, and speak English
  • A cancer survivor who has completed the recommended treatment of is receiving adjuvant endocrine therapy

Prostate

Unfavorable Intermediate/Favorable High Risk
0924
RTOG
Androgen Deprivation Therapy and High Dose Radiotherapy With or Without Whole-Pelvic Radiotherapy in Unfavorable Intermediate or Favorable High-Risk Prostate Cancer: A Phase III Randomized Trial NCT01368588

  • Histological or cytological proven prostatic adenocarcinoma within 180 days of registration at moderate to high risk for recurrence as determined by one of the following combinations:
    o Gleason score 7-10 + T1c-T2b (palpation) + PSA < 50 ng/ml (includes intermediate and high risk patients)
    o Gleason score 6 + T2c-T4 (palpation) or > 50% (positive) biopsies + PSA < 50 ng/ml
    o Gleason score 6 + T1c-T2b (palpation) + PSA > 20 ng/ml
  • Clinically negative lymph nodes as established by imaging (pelvic ± abdominal CT or MR within 90 days prior to registration) **PS 0-1
  • Patients with lymph nodes equivocal or questionable by imaging are eligible if the nodes are ≤ 1.5 cm
  • No evidence of bone Mets (M0) on bone scan within 120 days
  • No previous hormonal therapy, such as LHRH agonists
  • Prior pharmacologic androgen ablation for prostate ca is allowed only if the onset of androgen ablation is ≤ 45 days prior to registration
  • No finasteride within 30 days prior to registration
  • No dutasteride or dutasteride/tamsulosin (Jalyn) within 90 days
  • No previous or concurrent cytotoxic chemotherapy for prostate cancer.
  • Note that prior chemotherapy for a different cancer is allowable
  • No prior radiotherapy, including brachytherapy, to the region of the study cancer that would result in overlap of radiation therapy fields
  • Patients status post a negative lymph node dissection are not eligible

Upcoming Trials

A031501: Phase III Randomized Adjuvant study of MK-3475 (Pembrolizumab) in muscle-invasive and locally advanced urothelial carcinoma (AMBASSADOR) Versus Observation

A221504: A Randomized, Double-Blind, Placebo-Controlled Pilot of an Oral, Selective Peripheral Opioid Receptor Antagonist in Advanced Non-Small Cell Lung Cancer (Adenocarcinoma)

S1416: Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic Triple-Negative Breast Cancer (TNBC) and/or BRCA Mutation-Associated Breast Cancer