Cancer Clinical Trials

Clinical trials are research studies involving people that help investigators find new ways to prevent, detect, diagnose or treat cancer and other diseases. All of today’s successful treatments for cancer are based on results of past clinical trials. 

At MD Anderson Cancer Center at Cooper, our team of physicians, nurses and other cancer specialists work together bring the most innovative clinical trials to our patients. 

Through these clinical trials, patients have access to treatment options that may not be available elsewhere.  

If you or your family member is interested in being part of a clinical trial, please email ResearchCancer@cooperhealth.edu or review the list below of the current clinical trials offered at MD Anderson at Cooper. Thank you for thinking of Cooper to help you with your cancer diagnosis.

Breast Cancer Clinical Trials

A Phase 3, Randomized, Multi-center, Open-label Study of Trastuzumab Deruxtecan (T-DXd) Versus Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive Breast Cancer Patients whose Disease has Progressed on Endocrine Therapy in the Metastatic Setting

Principal Investigator: Kamel Abou Hussein, MD

Short Title: DESTINY

This study will evaluate the efficacy, safety and tolerability of trastuzumab deruxtecan compared with investigator's choice chemotherapy in human epidermal growth factor receptor (HER)2-low, hormone receptor (HR) positive breast cancer patients whose disease has progressed on endocrine therapy in the metastatic setting.

National Clinical Trial Identified Number: NCT04494425

Atorvastatin in triple-negative breast cancer (TNBC) patients who did not achieve a pathologic complete response (pCR) after receiving neoadjuvant chemotherapy; a multicenter pilot study

Principal Investigator: Kamel Abou Hussein, MD

Short Title: Atorvastatin

The hope for this study is to determine the proportion of patients with undetectable circulating tumor cells (CTCs) at 6 months in patients with stage IIB/III TNBC who did not achieve a pCR or Residual Cancer Burden-I (RCB-I) after receiving neoadjuvant chemotherapy (NAC) with and without atorvastatin therapy.

National Clinical Trial Identified Number: NCT03872388

A Randomized Trial of Hypofractionated Versus Conventionally Fractionated Regional Nodal Irradiation for Invasive Breast Cancer

Principal Investigator: Stuti Ahlawat, MD

Short Title: SAPHIRe

To compare the risk of developing lymphedema, defined as a 10% difference in volume between the affected and unaffected arm, within 24 months of RNI between patients assigned to short versus standard RNI.

National Clinical Trial Identified Number: NCT02912312

A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Adjuvant Atezolizumab or Placebo and Trastuzumab Emtansine for Her2-Positive Breast Cancer at High Risk of Recurrence Following Preoperative Therapy

Principal Investigator: Robert A Somer, MD

Short Title: WO42633

This is a Phase III, two-arm, randomized, double-blind placebo-controlled study in participants with HER2-positive primary breast cancer who have received preoperative chemotherapy and HER2-directed therapy, including trastuzumab followed by surgery, with a finding of residual invasive disease in the breast and/or axillary lymph nodes.National Clinical Trial Identified Number: NCT04873362

Using FDG PET to Assess Therapeutic Response in Patients with Bone-Dominant Metastatic Breast Cancer

Principal Investigator: Kamel Abou Hussein, MD

Short Title: FEATURE

This phase II trial studies how well FDG-PET/CT works in assessing the response of patients with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures, such as FDG-PET/CT, may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.

National Clinical Trial Identified Number: NCT04316117

Potential Impact of the Covid-19 Pandemic on Financial Toxicity in Breast Cancer Surgical Patients: The Impact On Out Of Pocket Costs, Lost Wages and Economic Strain

Principal Investigator: Steven C. Bonawitz, MD, FACS

Short Title: Financial Toxicity

This study investigates the impact of COVID-19 pandemic on out-of-pocket costs, lost wages, and unemployment in patients with breast cancer undergoing breast surgery. Post-mastectomy reconstructive patients are at high risk for financial toxicity (adverse effects of escalating health care cost on well-being). 

National Clinical Trial Identified Number: NCT04169542

A Phase II/III Study of Hypofractionated Partial Breast Irradiation in Women with Early Stage Breast Cancer

Principal Investigator: Stuti Ahlawat, MD

Short Title: OPAL II

This phase II trial studies how well hypofractionated partial breast irradiation works in treating patients with early stage breast cancer. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Treating only the part of the breast where the cancer started may lead to fewer side effects than standard treatment.

National Clinical Trial Identified Number: NCT03077841

Geographic Variation of Microbiome and Correlation with Treatment Response among Patients with Breast Cancer

Principal Investigator: Robert A. Somer, MD

Short Title: Microbiome

This study aims to characterize microbiome of breast cancer patients and correlate it to response to therapy for patients who are newly diagnosed breast cancer planning neoadjuvant chemotherapy

National Clinical Trial Identified Number: N/A

High-Risk Breast Cancer Registry

Principal Investigator: Jenia Jenab-Wolcott, MD, PhD

The purpose of this registry is to collect data on patients at high risk for breast cancer or who have been diagnosed with breast cancer at MD Anderson Cancer Center at Cooper. The importance of the registry is to create a single institution database of individuals (men or women) at increased risk for developing breast cancer or individuals who have had a prior history of breast cancer. The data provided by a site-specific cancer registry can play a significant role in future planning of cancer control programs, in screening and early detection, and in contributing to improved breast cancer care.

National Clinical Trial Identified Number: N/A

Gastrointestinal Cancer Clinical Trials

Phase II/III Study of Circulating tumOr DNA as a Predictive BiomaRker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer

Principal Investigator: Kinjal Kiran Dargan, MD

Short Name: GI005

This phase II/III trial studies how well circulating tumor deoxyribonucleic acid (ctDNA) testing in the blood works in predicting treatment for patients with stage IIA colon cancer after surgery. ctDNA are circulating tumor cells that are shed by tumors into the blood. Finding ctDNA in the blood means that there is very likely some small amounts of cancer that remain after surgery. However, this cancer, if detected, cannot be found on other tests usually used to find cancer, as it is too small. Testing for ctDNA levels may help identify patients with colon cancer after surgery who do benefit, and those who do not benefit, from receiving chemotherapy.

National Clinical Trial Identified Number: NCT04068103

High-Risk Colorectal Cancer Registry Program

Principal Investigator: Steven McClane, MD

The purpose of this registry is to create and maintain a prospective and retrospective database of patients with early-onset colorectal cancer or who are at increased risk for colorectal cancer based on germline gene mutation status, personal history of cancer, and/or family history of cancer.

National Clinical Trial Identified Number: N/A

Minimal Residual Disease Assessment in Colorectal Cancer

Principal Investigator: Jamin Morrison, MD

Short Name: MiRDA

This study will demonstrate ability to monitor cancer-specific DNA, RNA, and proteomic alterations from plasma and improve detection of recurrences post completion of curative therapies through monitoring of plasma cancer-specific DNA, RNA and proteomic alterations

National Clinical Trial Identified Number: N/A

Genitourinary Cancer Clinical Trials

Randomized Phase III Trial Incorporating Apalutamide and Advanced Imaging into Salvage Treatment for Patients with Node-Positive Prostate Cancer after Radical Prostatectomy (Innovate*)*INtensifying treatment for NOde positive prostate cancer by VArying the hormonal ThErapy

Principal Investigator: Gary Eastwick, MD

Short Title: GU008

This phase III trial studies whether adding apalutamide to the usual treatment improves outcome in patients with lymph node positive prostate cancer after surgery. 

National Clinical Trial Identified Number: NCT04134260

Parallel Phase III Randomized Trials for High Risk Prostate Cancer Evaluating De-Intensification for Lower Genomic Risk and Intensification of Concurrent Therapy for Higher Genomic Risk with Radiation (PREDICT-RT*) *Prostate RNA Expression/Decipher To Individualize Concurrent Therapy with Radiation

Principal Investigator: Gary Eastwick, MD

Short Title: GU009

This phase III trial compares less intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in treating patients with high risk prostate cancer and low gene risk score. This trial also compares more intense hormone therapy and radiation therapy to usual hormone therapy and radiation therapy in patients with high risk prostate cancer and high gene risk score.

National Clinical Trial Identified Number: NCT04513717

Parallel Phase III Randomized Trials of Genomic-Risk Stratified Unfavorable Intermediate Risk Prostate Cancer: De-Intensification And Intensification Clinical Trial Evaluation (Guidance)

Principal Investigator: Gary Eastwick, MD

Short Title: GU010

This phase III trial uses the Decipher risk score to guide intensification (for higher Decipher gene risk) or de-intensification (for low Decipher gene risk) of treatment to better match therapies to an individual patient's cancer aggressiveness. The Decipher risk score evaluates a prostate cancer tumor for its potential for spreading. In patients with low risk scores, this trial compares radiation therapy alone to the usual treatment of radiation therapy and hormone therapy (androgen deprivation therapy).

National Clinical Trial Identified Number: NCT04513717

Phase III Study of Local or Systemic Therapy INtensification DIrected by PET in Prostate CAncer Patients with Post-ProstaTEctomy Biochemical Recurrence

Principal Investigator: Gary Eastwick, MD

Short Title: INDICATE

This phase III trial compares the addition of apalutamide, with or without targeted radiation therapy, to standard of care treatment versus standard of care treatment alone in patients with prostate cancer biochemical recurrence (a rise in the blood level of prostate-specific antigen [PSA] after treatment with surgery or radiation).

National Clinical Trial Identified Number: NCT04423211

Gynecologic Cancer Clinical Trials

A Phase 1b/2, First-in-Human, Dose Escalation and Expansion Study of XMT-1536 in patients with Solid Tumors Likely to Express NaPi2b

Principal Investigator: David Warshal, MD

Short Title: GOG 3048

This is a multi-center study of XMT-1536 (upifitamab rilsodotin) in patients with tumors likely to express NaPi2b, focusing on patients with platinum-resistant ovarian cancer and non-small cell lung cancer, adenocarcinoma subtype. XMT-1536 (upifitamab rilsodotin) will be administered as an intravenous infusion once every four weeks. The study consists of three segments: dose escalation (DES), dose expansion (EXP), and the pivotal cohort (UPLIFT). The DES segment studied small groups of patients who received increased doses

National Clinical Trial Identified Number: NCT03319628

A Phase I/II study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

Principal Investigator: David Warshal, MD

Short Title: Ovation 201-17-201

This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.

National Clinical Trial Identified Number: NCT03393884

A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone Or In Combination with IV Triapine in Women with Newly Diagnosed Bulky Stage 1B2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix Or Stage II-IVA Vaginal Cancer

Principal Investigator: David Warshal, MD

Short Title: GY006

This randomized phase III trial studies radiation therapy and cisplatin with triapine to see how well they work compared to the standard radiation therapy and cisplatin alone in treating patients with newly diagnosed stage IB2, II, or IIIB-IVA cervical cancer or stage II-IVA vaginal cancer.

National Clinical Trial Identified Number: NCT02466971

Phase II Study of the Levonorgestrel Intrauterine Device Alone or in Combination with the mTORC1 Inhibitor, Everolimus, for the Treatment of Complex Atypical Hyperplasia and Stage Ia Grade 1 Endometrial Cancer

Principal Investigator: David Warshal, MD

Short Title:  LEVER

This randomized phase II trial studies how well levonorgestrel-releasing intrauterine system works when given alone or with Everolimus in treating patients with atypical hyperplasia (a pre-cancerous growth of the lining of the uterus) or stage IA grade 1 endometrial cancer.

National Clinical Trial Identified Number: NCT02397083

An Open-Label Randomized Active-Controlled Phase II Clinical Study to Assess the Efficacy and Safety of Afuresertib Plus Paclitaxel Versus Paclitaxel in Patients with Platinum-Resistant Ovarian Cancer

Principal Investigator: David Warshal, MD

Short Title: LAEKNA

Afuresertib is an AKT inhibitor, a new class of agents under development that may provide physicians with a new clinical option to control platinum resistant ovarian cancer (PROC) progression.

National Clinical Trial Identified Number: NCT04374630

A Phase III Randomized Trial of Radiation +/- Pembrolizumab (Mk-3475) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

Principal Investigator: David Warshal, MD

Short Title: GY020

This phase III trial compares whether the addition of pembrolizumab to radiation therapy is more effective than radiation therapy alone in reducing the risk of cancer coming back (recurrence) in patients with newly diagnosed stage I-II endometrial cancer.

National Clinical Trial Identified Number: NCT04214067

A Randomized Phase III, Two-Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II-IV, Primary Low-Grade Serous Carcinoma of the Ovary or Peritoneum

Principal Investigator: David Warshal, MD

Short Title: GY019

This phase III trial studies how well letrozole with or without paclitaxel and carboplatin works in treating patients with stage II-IV low-grade serous carcinoma of the ovary, fallopian tube, or peritoneum. Letrozole is an enzyme inhibitor that lowers the amount of estrogen made by the body which in turn may stop the growth of tumor cells that need estrogen to grow. 

National Clinical Trial Identified Number: NCT04095364

Head and Neck Cancer Clinical Trials

Phase II Trial of Magnetic Resonance Imaging Guided Radiotherapy Dose Adaption I Human Papilloma Virus Positive Oropharyngeal Cancer

Principal Investigator: Megan Mezera, MD

Short Title: MR Linac

The goal of this clinical research study is to compare the use of MRI simulations to plan different doses of intensity modulated radiotherapy (IMRT) to the standard IMRT dose in patients with low risk human papilloma virus positive oropharyngeal cancer.

National Clinical Trial Identified Number: NCT03224000

A randomized study of head and neck radiotherapy with or without customized 3D printed oral stents

Principal Investigator: Gregory Kubicek, MD

Short Title: Oral 3D Stent

The primary objective of this randomized trial is to evaluate the acute mucositis rates in non-target mucosa of patients who receive head and neck radiation with or without a customized 3D printed oral stent.

National Clinical Trial Identified Number: NCT04870762

Hematology Clinical Trials

Phase III Study of Daratumumab (NSC- 791647) + Lenalidomide (LD) or Lenalidomide (L) as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

Principal Investigator: Tulin Budak-Alpdogan, MD

Short Title: S1803

This clinical trial offers treatment to patients with multiple myeloma who have undergone ASCT, a type of transplant that uses a patient's own stem cells (cells in the bone marrow that produce new blood cells) to replace those normal cells that are damaged by the high dose chemotherapy treatment that is given to kill cancer cells. Because there is a possibility of cancer returning even after ASCT, patients typically receive maintenance treatment, with the goal of preventing or delaying the return of cancer. In this clinical trial, one group of patients will be randomly assigned to receiving the standard maintenance treatment for multiple myeloma — an immunomodulatory drug called lenalidomide - which works by stimulating cells in the immune system, decreasing the blood supply to tumors, and inhibiting the growth of cancer cells.National Clinical Trial Identified Number: NCT04071457

Lung Cancer Clinical Trials

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (Lung)

Principal Investigator: Young Hong, MD

Short Title: IOV-LUN-202

This study is to evaluate the efficacy of LN-145 in patients with metastatic NSCLC without an actionable driver mutation who have disease progression on or following a single line of approved systemic therapy consisting of combined immune checkpoint inhibitor(s) (CPI[s]) + chemotherapy ± bevacizumab

National Clinical Trial Identified Number: NCT03645928

Melanoma Clinical Trials

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors (Melanoma)

Principal Investigator: Young Hong, MD

Short Title: IOV-COM-202

This study is to evaluate the efficacy of autologous TIL in combination with CPIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients National Clinical Trial Identified Number: NCT03645928

Multi-Disease Site Clinical Trials

A Phase II, Multicenter Study of Autologous Tumor Infiltrating Lymphocytes (LN-144 or LN-145) in Patients with Solid Tumors Melanoma, H/N, Lung

Principal Investigator: Young Hong, MD

Short Title: IOV-COM-202

This study is to evaluate the efficacy of autologous TIL in combination with CPIs in metastatic melanoma, HNSCC, and NSCLC patients and as a single therapy in metastatic melanoma and NSCLC patients.

National Clinical Trial Identified Number: NCT03645928

A Pre-Consultation Compassion Intervention to Reduce Anxiety Among Patients Referred to a Cancer Center: Protocol for a Randomized Control Trial

Principal Investigator: Brian Roberts, MD

Short Title: Compassion

The aim of this randomized control trial is to test if watching a brief video containing compassionate statements from an oncologist, compared to watching a standard introduction video, prior to an initial oncology consultation will reduce the degree of anxiety among patients referred to a cancer center.

National Clinical Trial Identified Number: NCT04503681

Orthopaedic Oncology Clinical Trials

Genomic Analysis of Bone Sarcomas 

Principal Investigator: Tae Kim, MD

Short Title: PA14-1067

The objectives of the study are to better understand the role of genomic alterations in bone sarcoma patients whose cancers have either progressed on therapy, after a period of response, or were refractory to initial "first-line" treatment.

National Clinical Trial Identified Number: N/A

 

Contact Us

For more information about cancer clinical trials at MD Anderson at Cooper, please email ResearchCancer@cooperhealth.edu. Thank you.