Oncology Research Program

Highlights of the NCCN Oncology Research ProgramThe NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.Several NCCN-sponsored studies funded through the grant mechanism are highlighted below.Phase I/II Study of Carboplatin and Pralatrexate in Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian, or Primary Peritoneal CancerPrincipal Investigator: Marcela G. del Carmen, MD, MPHCondition: Ovarian cancer; fallopian tube cancer; peritoneal cancerInstitutions: Massachusetts Hospital, Dana Farber Cancer InstituteEach study cycle will last 28 days. On day 1, participants will receive carboplatin intravenously. On days 1 and 15 of each cycle, they will receive pralatrexate intravenously. Participants will also be asked to take folic acid orally daily starting 7 days before the first dose of pralatrexate and continuing until 30 days after the last dose of pralatrexate. They will receive a vitamin B12 injection no more than 10 weeks before the first dose of pralatrexate and every 8 to 10 weeks...

Highlights of the NCCN Oncology Research Program

The NCCN Oncology Research Program (ORP) strives to improve the quality of life for patients and reduce cancer-related deaths by advancing cancer therapies through research. Since the program's establishment in 1999, the NCCN ORP has brought millions of dollars in research grants to investigators at NCCN Member Institutions. Research grants are provided to NCCN through collaborations with pharmaceutical and biotechnology companies; these grants are in turn used to support scientifically meritorious cancer research efforts.

NCCN ORP studies typically explore new avenues of clinical investigation and seek answers to important cancer-related questions. All studies are approved and funded through a scientific peer-review process and are overseen by the ORP.

Several NCCN-sponsored studies funded through the grant mechanism are highlighted below.

Phase I/II Study of Carboplatin and Pralatrexate in Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian, or Primary Peritoneal Cancer

Principal Investigator: Marcela G. del Carmen, MD, MPH

Condition: Ovarian cancer; fallopian tube cancer; peritoneal cancer

Institutions: Massachusetts Hospital, Dana Farber Cancer Institute

Each study cycle will last 28 days. On day 1, participants will receive carboplatin intravenously. On days 1 and 15 of each cycle, they will receive pralatrexate intravenously. Participants will also be asked to take folic acid orally daily starting 7 days before the first dose of pralatrexate and continuing until 30 days after the last dose of pralatrexate. They will receive a vitamin B12 injection no more than 10 weeks before the first dose of pralatrexate and every 8 to 10 weeks after the first dose of pralatrexate.

Participants will come to the clinic on days 1 and 15 of each cycle and undergo the following tests or procedures: medical history, vital signs, blood tests, assessment of the tumor (every 2 cycles), and an EKG (before the start of cycle 2). In addition, during cycle 1, participants will come to the clinic weekly for blood tests. Pharmacokinetic blood samples (to monitor how the body absorbs and breaks down the study drug) will be performed during cycle 1 on day 1 to 3 and day 15 to 17.

Participants will be asked to take the study drugs for up to 6 cycles. They may continue beyond 6 cycles as long as evidence shows that the tumor is not growing and they do not experience unacceptable side effects.

Primary Outcome Measures:

  • Identify the maximum tolerated dose of pralatrexate in combination with carboplatin in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

  • Assess response rate of carboplatin-pralatrexate combination using an every-28-day schedule in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer

Secondary Outcome Measures:

  • Assess progression-free and overall survival in patients with recurrent, platinum-sensitive ovarian, fallopian tube, or peritoneal cancer treated with carboplatin and pralatrexate

  • Assess toxicities of treatment with combination carboplatin and pralatrexate in platinum-sensitive, recurrent ovarian, fallopian tube, and peritoneal cancer

  • Characterize the pharmacokinetics of carboplatin and pralatrexate used in combination

Contact: Marcela G. del Carmen, MD, MPH • 617-724-4800 • mdelcarmen@partners.org

ClinicalTrials.gov Identifier: NCT01188876

Neoadjuvant Weekly nab-Paclitaxel (Abraxane) Plus Carboplatin Followed By Doxorubicin Plus Cyclophosphamide With Bevacizumab Added Concurrently to Chemotherapy for Palpable and Operable Triple Negative Invasive Breast Cancer

Principal Investigator: Jasgit C. Sachdev, MD

Condition: Triple negative breast cancer

Institution: University of Tennessee Cancer Institute

This study is to determine how well this combination of chemotherapy drugs works with bevacizumab in eliminating primary tumor in the breast before surgery (pathologic complete response [pCR] in the breast). Bevacizumab works by blocking new blood vessel formation by the tumor cells. Giving chemotherapy and bevacizumab before surgery may allow for a lesser amount of breast tissue to be removed. To be able to predict in the future which patients are more likely to get pCR to this drug combination, specialized tests on fresh tumor tissue collected before start of treatment will be performed.

Major Eligibility Criteria: Patients with histologically proven ER-, PR-, and HER2-negative (triple negative) breast cancer that is 2 cm or greater in size, clinically palpable, and considered operable are eligible. Patients with T4 and inflammatory cancers are ineligible.

Primary Objective:

  • pCR in the breast

Secondary Objectives:

  • Determine the rate of near pCR, defined as 0.5 cm or less of residual invasive tumor in the breast

  • Determine the rate of pCR in the breast and axillary nodes and nonaxillary sentinel nodes

  • Determine clinical response rates (cRR: complete plus partial response rates) after treatment with 4 cycles of nab-paclitaxel plus carboplatin with concurrent bevacizumab

  • Determine cRR after treatment with all 8 cycles of neoadjuvant treatment

  • Determine the rate of breast-conserving surgery after completion of neoadjuvant therapy

  • Determine safety and tolerability of the above regimen, including cardiac safety

  • Determine disease-free survival

  • Identify genes that may predict pCR to the study regimen

Contact: Steve K. West, BS, CCRP • 901-722-0581 • swest@utcancer.com

ClinicalTrials.gov Identifier: NCT00777673

The goal of the Highlights of the NCCN Oncology Research Program (ORP) is to provide readers with more information on the ORP, including studies currently accruing patients.

For more information on specific trials, including patient selection criteria, please use the contact information listed with each study.

For more information on the NCCN ORP, including a complete detailing of the clinical studies currently underway at NCCN Member Institutions, please access the NCCN ORP pages at http://www.nccn.org/clinical_trials/clinicians.asp.

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