Cancer Research Study

Breast

ALLIANCE A011106 NCI CIRB
Alternate Approaches for Clinical Stage II or III Estrogen Receptor Positive Breast Cancer Neoadjuvant Treatment (ALTERNATE) in Postmenopausal Women:
A Phase III Study

Why the study is being done/Purpose:
PURPOSE: This randomized phase III trial has several primary objectives. One primary objective is to compare the efficacy of 3 different endocrine therapies, the estrogen receptor down regulator fulvestrant and the aromatase inhibitor anastrozole, either alone or in combination, in reducing cancer growth before surgery (neoadjuvant) in postmenopausal women with clinical stage II-III estrogen receptor positive and HER2 negative breast cancer. Another primary objective is to evaluate whether patients who achieved a modified PEPI (Preoperative Endocrine Prognostic Index) score of 0, defined by tumor size <5 cm, N0, Ki67<2.7% (by central testing), at surgery post 6 months of neoadjuvant endocrine therapy predict excellent long term outcome, for whom chemotherapy is unnecessary.

Breast

NRG-BR003 (NCI CIRB)
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.

Why the study is being done/Purpose:
PURPOSE/RATIONALE: The purpose of this study the effects of the chemotherapy drug, carboplatin, given with the usual chemotherapy drugs after surgery, compared to the usual chemotherapy drugs given without carboplatin. This study will allow the researchers to know whether giving carboplatin with the usual chemotherapy is better, the same, or worse than giving the usual chemotherapy. Carboplatin is FDA-approved for the treatment of cancer and is used for the treatment of breast cancer that has spread, but it has not yet been proven useful in earlier stages of breast cancer.

Breast

Alliance A011502 NCI CIRB
A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for Node Positive HER2 Negative Breast Cancer: The ABC Trial

Why the study is being done/Purpose:
RATIONALE/PURPOSE: This randomized phase III trial studies how well aspirin works in preventing the cancer from coming back (recurrence) in patients with human epidermal growth factor receptor 2 (HER2) breast cancer after chemotherapy, surgery, and/or radiation therapy. Aspirin is a drug that reduces pain, fever, inflammation, and blood clotting. It is also being studied in cancer prevention. Giving aspirin may reduce the rate of cancer recurrence in patients with breast cancer

Breast

Alliance A011401 NCI CIRB
Randomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer [Breast Cancer WEight Loss Study (BWEL Study)]

Why the study is being done/Purpose:
This randomized phase III trial studies whether weight loss in overweight and obese women may prevent breast cancer from coming back (recurrence). Previous studies have found that women who are overweight or obese when their breast cancer is found (diagnosed) have a greater risk of their breast cancer recurring, as compared to women who were thinner when their cancer was diagnosed. This study aims to test whether overweight or obese women who take part in a weight loss program after being diagnosed with breast cancer have a lower rate of cancer recurrence as compared to women who do not take part in the weight loss program. This study will help to show whether weight loss programs should be a part of breast cancer treatment.

GI Colon

SWOG S0820 CTSU
A Double Blind Placebo-Controlled Trial of Eflornithine and Sulindac to Prevent Recurrence of High Risk Adenomas and Second Primary Colorectal Cancers in
Patients with Stage 0-III Colon or Rectal Cancer, Phase III – Preventing Adenomas of the Colon with Eflornithine and Sulindac (PACES)

Why the study is being done/Purpose:
The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon cancer or rectal cancer.

GI Lower - Colorectal

Alliance A021502 NCI CIRB
A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/MSWOG S1613 NCI CIRBetastatic Colorectal Cancer (MCRC) with HER-2 ASWOG S1613 NCI CIRBmplification

Why the study is being done/Purpose:
This randomized phase II trial studies how well trastuzumab and pertuzumab work compared to cetuximab and irinotecan hydrochloride in treating patients with
HER2/neu amplified colorectal cancer that has spread from where it started to other places in the body and cannot be removed by surgery. Monoclonal antibodies,
such as trastuzumab and pertuzumab, may interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy, such as cetuximab and
irinotecan hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from
spreading. Giving trastuzumab and pertuzumab may work better compared to cetuximab and irinotecan hydrochloride in treating patients with colorectal cancer.

GU - Gastroenteropancreatic

ECOG-ACRIN EA2142 NCI CIRB
Randomized Phase II Study of Cisplatin and Etoposide versus Temozolomide and Capecitabine in Patients with Advanced G3 Non-Small Cell Gastroenteropancreatic Neuroendocrine Carcinomas

Why the study is being done/Purpose:
RATIONALE/PURPOSE: This randomized phase II trial studies how well temozolomide and capecitabine work compared to standard treatment with cisplatin and etoposide in treating patients with neuroendocrine carcinoma of the gastrointestinal tract or pancreas that has spread to other parts of the body (metastatic) or cannot be removed by surgery. Drugs used in chemotherapy, such as temozolomide, capecitabine, cisplatin, and etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Certain types of neuroendocrine carcinomas may respond better to treatments other than the current standard treatment of cisplatin and etoposide. It is not yet known whether temozolomide and capecitabine may work better than cisplatin and etoposide in treating patients with this type of neuroendocrine carcinoma, called non-small cell neuroendocrine carcinoma

GU - Prostate

NRG RTOG-0924 (NCI CIRB)
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

Why the study is being done/Purpose:
PURPOSE/RATIONALE: Androgens can cause the growth of prostate cancer cells. Androgen deprivation therapy may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. This randomized phase III trial studies androgen-deprivation therapy and radiation therapy in treating patients with prostate cancer.

Hematology-MDS

NHLBI-MDS NCI CIRB
The National Myelodysplastic Syndromes (MDS) Natural History Study.

Why the study is being done/Purpose:
PURPOSE: The goal of the National MDS Study is to establish a publicly available resource to facilitate the study of MDS natural history. This will be accomplished through:
1) Creation of a multi-institutional, longitudinal collection of consistently processed and clinically well-annotated blood and tissue specimens collected prospectively from participants with MDS and participants with idiopathic cytopenia of undetermined significance (ICUS);
2) Support for investigator-initiated studies of MDS that will have high-impact for MDS patients, including basic science, clinical, health outcomes and epidemiological research.

Lung, Non-small Cell

ALLIANCE A081105 CIRB – ALCHEMIST – EGFR Tx
Randomized Study of Erlotinib or Observation in Patients with Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non-small Cell Lung Cancer (NSCLC)

Why the study is being done/Purpose:
ALCHEMIST STUDY (EGFR Treatment Component)
PURPOSE: This randomized phase III trial studies how well erlotinib hydrochloride compared to placebo works in treating patients with stage IB-IIIA non-small cell lung cancer that has been completely removed by surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Lung, Non-small Cell

ALLIANCE A151216 CIRB – ALCHEMIST –
Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST).

Why the study is being done/Purpose:
ALCHEMIST STUDY (Screening Component)

PURPOSE: This research trial studies genetic testing in screening patients with stage IB-IIIA non-small cell lung cancer that has been or will be removed by surgery. Studying the genes in a patient’s tumor cells may help doctors select the best treatment for patients that have certain genetic changes.

Lung, Non-small Cell

ECOG-ACRIN E4512 CIRB – ALCHEMIST – ALK Tx
A Randomized Phase III Trial for Surgically Resected Early Stage Non-Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

Why the study is being done/Purpose:
ALCHEMIST STUDY (ALK Treatment Component)
PURPOSE: This randomized phase III trial studies how well crizotinib works and compares it to placebo in treating patients with stage IB-IIIA non-small cell lung cancer that has been removed by surgery and has a mutation in a protein called ALK. Mutations, or changes, in ALK can make it very active and important for tumor cell growth and progression. Tumors with this mutation may respond to treatments that target the mutation, such as crizotinib. Crizotinib may stop the growth of tumor cells by blocking the ALK protein from working. It is not yet known if crizotinib may be an effective treatment for treating non-small cell lung cancer with an ALK fusion mutation.

Lung, Non-small Cell

ECOG-ACRIN EA5142 NCI CIRB
Adjuvant Nivolumab in Resected Lung Cancers (ANVIL) – A Randomized Phase III Study of Nivolumab After Surgical Resection and Adjuvant Chemotherapy in Non-small Cell Lung Cancers.

Why the study is being done/Purpose:
ALCHEMIST STUDY
PURPOSE: This randomized phase III trial studies how well nivolumab after surgery and chemotherapy work in treating patients with stage IB-IIIA non-small cell
lung cancer. Monoclonal antibodies, such as nivolumab, may stimulate the immune system in different ways and kill tumor cells remaining after surgery and
standard of care chemotherapy.

Melanoma

ECOG-ACRIN EA6134 NCI CIRB
A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients With Advanced BRAFV600 Mutant Melanoma.

Why the study is being done/Purpose:
RATIONALE/PURPOSE: This randomized phase III trial studies how well initial treatment with ipilimumab and nivolumab followed by dabrafenib and trametinib works and compares it to initial treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab in treating patients with stage III-IV melanoma that contains a mutation known as v-raf murine sarcoma viral oncogene homolog B V600 (BRAFV600) and cannot be removed by surgery. Ipilimumab and nivolumab may block tumor growth by targeting certain cells. Dabrafenib and trametinib may block tumor growth by targeting the BRAFV600 gene. It is not yet known whether treating patients with ipilimumab and nivolumab followed by dabrafenib and trametinib is more effective than treatment with dabrafenib and trametinib followed by ipilimumab and nivolumab.

Rare Tumors

SWOG S1609 (NCI CIRB)
DART: Dual Anti-CTLA-4 and Anti-PD-1 Blockade in Rare Tumors.

Why the study is being done/Purpose:
Rational and Purpose: This clinical trial studies nivolumab and ipilimumab in treating patients with rare tumors. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread.