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Clinical trials, also called medical research or research studies, answer specific questions about new therapies or new ways to use known treatments. They are used to test new drugs and new approaches to surgery or radiation therapy. Clinical trials are available to patients meeting certain criteria. Patients who volunteer to participate in clinical trials have the opportunity to contribute to cancer research. They also receive up-to-date care from healthcare professionals.

Clinical trials at the Payson Center for Cancer Care are available through New Hampshire Oncology-Hematology PA (NHOH). The medical oncologists at NHOH are members of Cancer and Leukemia Group B (CALGB), and the Cancer Trials Support Unit. As members of these groups, they have access to studies sponsored by the National Cancer Institute’s Clinical Trials Groups, in addition to CALGB studies.

Radiation clinical trials are available through the Concord Hospital Jim and Marianne Cook Radiation Oncology Department as an affiliate member of the Radiation Therapy Oncology Group.

Payson Center for Cancer Care Clinical Trials

Contact your oncologist for more information about the clinical trials listed below.

Breast Cancer

CTSU N063D: ALTTO-adjuvant lapatinib and/or transtuzumab treatment optimization study: A randomized, multi-centre, open label, phase III study of adjuvant lapatinib, trastuzumab, their sequence and their combination in patients with HER2/ErbB2 positive primary breast cancer.

  • Patients who have HER2+ early breast cancer may be eligible for this study. All patients will receive paclitaxel and then would be enrolled into one of four groups to receive: standard treatment – trastuzumab; lapatinib; trastuzumab and then lapatinib; or trastuzmab and lapatinib together for up to 1 year. Paclitaxel and trastuzmab are given in the vein and lapatinib is a pill.

CTSU ECOG E5103 A double-blind Phase III trial of doxorubicin and cyclophosphamide followed by paclitaxel with bevacizumab or placebo in patients with lymph node positive and high risk lymph node negative breast cancer.

  • Patients with lymph node positive and high risk lymph node negative breast cancer may be eligible for this study. Patients would be randomized to one of three groups. The main purpose of the study is to determine whether adding bevacizumab with the current standard chemotherapy medications reduces the risk of recurrence.

CALGB 40302 Endocrine therapy with or without inhibition of EGF and HER2 growth factor receptors: A randomized, double-blind, placebo-controlled phase III trial of fulvestrant with or without lapatinib (GW572016) for postmenopausal women with hormone receptor positive advanced breast cancer.

  • Post-menopausal women with advanced breast cancer may be eligible for this study to see if adding a new anti-cancer drug, lapatinib, can add to the benefits of the standard anti-estrogen drug fulvestrant. Patients who enroll would receive either a Fulvestrant injection and a lapatinib tablet or Fulvestrant injection and a placebo tablet (a tablet that looks like the investigational agent but doesn’t have any medication in it) for 28 days.

NSABP B42 A clinical trial to determine the efficacy of 5 years of letrozole compared to placebo in patients completing 5 years of hormonal therapy consisting of an aromatase inhibitor (AI) or tamoxifen followed by an AI in prolonging disease-free survival in postmenopausal women with hormone receptor positive cancer.

  • Women who have had 5 years of hormone therapy for breast cancer are eligible to enroll in this study which will investigate whether an additional 5 years of hormone therapy with letrozole may further reduce the chance of breast cancer returning.

Program for the Assessment of Clinical Cancer Tests (PACCT) Trial Assigning IndividuaLized Options for Treatment (TAILORx)

  • Women with localized breast cancer will have a diagnostic test that indicates the possible risk of disease recurrence. Based on their test results, women will be assigned to one of three study groups in which they will receive hormone therapy, chemotherapy, or both.

S0307 Phase III trial of bisphosphonates as adjuvant therapy for primary breast cancer.

  • Women with stage I, II, or III breast cancer currently in remission are eligible to participate in this study to investigate whether adding a bone-strengthening drug to hormone therapy or to chemotherapy may help to prevent cancer from spreading to the bones or to other parts of the body.

NCIC MA.27 A randomized phase III trial of exemestane versus anastrozole in postmenopausal women with receptor positive primary breast cancer.

  • Women who have had surgery to remove breast cancer and who may or may not have received chemotherapy will be randomly assigned to one of two hormone drugs to compare their ability to prevent the recurrence of breast cancer.

CTSU S0226 Phase III randomized trial of anastrozole versus anastrozole and fulvestrant as first line therapy for post menopausal women with metastatic breast cancer

  • Postmenopausal women with breast cancer that has spread will be randomly assigned to receive either one hormonal agent or a combination of two hormonal agents.

RTOG 0413 A randomized phase III study of conventional whole breast irradiation (WBI) versus partial breast irradiation (PBI) for women with stage 0, I, or II breast cancer.

  • Women who have a lumpectomy as surgery for breast cancer will be randomly assigned to receive whole breast irradiation or partial breast irradiation.

CALGB 40101 Cyclophosphamide and doxorubicin (CA 4 vs 6 cycles) versus paclitaxel (4 vs 6 cycles) as adjuvant therapy for women with node-negative breast cancer: A 2x2 factorial phase III randomized study.

  • Women with localized breast cancer who have not previously received chemotherapy and have had surgical resection will be randomly assigned to one of two different chemotherapy drug treatments.

CALGB 369901 Observational cohort study chemotherapy decisions and outcomes in women age 65 or older with operable, newly diagnosed breast cancer.

  • Women aged 65 or older who have recently had a positive biopsy or surgery for breast cancer may participate in this survey. The survey looks at how and why women make the decision to undergo or not to undergo chemotherapy as part of their treatment.

CTSU IBCSG 24-02(SOFT) A phase III trial evaluating the role of ovarian function suppression and the role of exemestane adjuvant therapies for premenopausal women with endocrine responsive breast cancer.

  • Premenopausal women who have had surgery for breast cancer will be randomized to one of three treatments: A drug which blocks the activity of estrogen
    OR

    A drug which blocks the activity of estrogen, with one of three options to prevent the ovaries from producing estrogen
    OR

    A drug that interferes with the body’s production of estrogen, together with one of three options to prevent the ovaries from producing estrogen

CTSU S0221 A phase III trial of continuous schedule adriamycin+cytoxan, versus every 2 week schedule of adriamycin+cytoxan, followed by paclitaxel given either very 2 weeks or weekly for 12 weeks as postoperative adjuvant therapy in node-positive or high risk node-negative breast cancer.

  • Patients who have had surgery for breast cancer will be randomly assigned to one of four chemotherapy treatments, all including essentially the same drugs but given in different ways and on different schedules.

Brain Cancer

RTOG 0525 A phase III trial comparing conventional adjuvant temozolomide with dose-intensive temozolomide in patients with newly diagnosed glioblastoma.

  • Patients with glioblastoma who enroll in this study will receive radiation therapy and temozolomide, then receive temozolomide for 5 days a month versus 21 days a month for up to one year.

Colorectal Cancer

N0147 A randomized phase III trial of oxaliplatin (OXAL) plus 5-fluorouracil (5-FU)/leucovorin (CF) with or without cetuximab (C225) after curative resection for patients with stage III colon cancer.

  • Patients with stage III colon cancer who have undergone surgery are eligible to be randomly assigned to receive either a set of standard chemotherapy drugs or standard drugs plus an investigational drug.

ECOG 5202 A randomized phase III study comparing 5-FU, leucovorin, and oxaliplatin to the same chemotherapy with bevacizumab in patients with stage II colon cancer at high risk for recurrence, to determine prospectively the prognostic value of molecular markers.

  • Patients with locally advanced colon cancer will have a test that shows that the individual may be a high risk for tumor recurrence. Patients who may be at high risk will receive standard chemotherapy with or without an additional investigational drug. Patient who may be at low risk for recurrence will be monitored carefully but will not need chemotherapy at this time.

CALGB/SWOG 80405 A phase III trial of irinotecan/5-FU/leucovorin or oxaliplatin/5-FU/leucovorin with bevacizumab, or cetuximab (C225), or with the combination of bevacizumab and cetuximab for patients with untreated metastatic adenocarcinoma of the colon or rectum.

  • Patients with cancer of the colon or rectum which has spread and has not yet been treated will be randomly assigned to receive one of two standardized chemotherapy treatments with an additional approved drug
    OR
    one of two standardized chemotherapy treatments with an experimental drug
    OR
    one of two standardized chemotherapy treatments with both of these two additional drugs.

Gastrointestinal Cancer

CALGB 80302 A Phase II trial of preoperative irinotecan, cisplatin, and radiation in esophageal cancer.

  • Individuals diagnosed with localized esophageal cancer are eligible for this study. Participants will receive chemotherapy and radiation therapy before surgery, rather than surgery alone or chemotherapy and radiation without surgery.

CALGB 80101 A phase III trial of adjuvant chemoradiation after resection of gastric and gastroesophageal adenocarcinoma.

  • Patients who have undergone surgical resection for cancer of the stomach or of the lower esophagus will be randomly assigned to receive either a regimen of two drugs plus radiation therapy or a regimen of three drugs plus radiation therapy.

Head and Neck Cancer

RTOG 0522 (A randomized phase III trial of concurrent accelerated radiation and cisplatin versus concurrent accelerated radiation, cisplatin, and cetuxumab (C225). (Followed by surgery for selected patients) for stage III and IV head and neck carcinomas).

  • Patients eligible who have advanced head and neck cancer would be enrolled into one of two treatment arms to receive either radiation therapy and chemotherapy (cisplatin) or an initial dose of cetuxumab (C225) then radiation therapy, cetuxumab (C225) and chemotherapy (cisplatin) to evaluate different radiation treatments in combination with chemotherapy and cetuximab. The chemotherapy and cetuximab are given in the vein. The active treatments will last up to seven weeks.

CTSU E1302 Phase III randomized, placebo controlled trial of docetaxel versus docetaxel plus ZD1839 in performance status 2 or previously treated patients with recurrent or metastatic head and neck cancer.

  • Patients with head and neck cancer that has spread or has recurred may take part in this study. Patient will be randomly assigned to receive a standard chemotherapeutic drug together with a placebo, or a standard chemotherapeutic drug together with an investigational drug.

Lung Cancer

CALGB 30605: A phase II study of induction chemotherapy followed by thoracic radiotherapy and erlotinib in poor-risk stage III non small cell lung cancer (NSCLC).

  • Patients eligible who have stage III NSCLC that cannot be removed by surgery will receive induction chemotherapy with albumin-bound paclitaxel and carboplatin in their vein then will received concurrent radiotherapy and erlotinib, which is a pill, for up to 16 weeks.

CTSU E1505 A phase III randomized trial of adjuvant chemotherapy with or without bevacizumab for patients with completely resected stage 1B (>4 cm) - 111A non small cell lung cancer (NSCLC).

  • Patients eligible for this trial would have surgery for the removal of their lung cancer and would receive standard chemotherapy. Patients would then be randomly assigned to receive either a placebo or the investigational drug, bevacizumab. Bevacizumab is given intravenously.

CALGB 30504 A Phase IB/II Study of the combination Cisplatin, Etoposide and Sunitinib for untreated extensive stage small cell lung cancer.

  • Cisplatin and Etoposide are currently approved for use in patients with extensive small cell lung cancer. This study adds the medication, Sunitinib. Sunitinib is an oral medication that inhibits VEGF (Vascular Endothelial Growth Factor). VEGF levels are elevated in many of these malignancies. In this study, a small number of patients will participate first to determine the best dose of Sunitinib combined with Cisplatin and Etoposide. Then a larger group of patients will receive that dose and be followed for a period of time.

S0424 A molecular epidemiology case-series study of non-small cell lung cancer in smoking and non-smoking women and men.

  • Men and women who are newly diagnosed with non-small cell lung cancer are eligible for this study. The researchers will assess tissue samples for specific tobacco smoke carcinogens in both smokers and non-smokers.

CALGB 79803 A phase III chemoprevention trial of selenium supplementation in persons with resected stage I non-small-cell lung cancer.

  • Patients who have had surgical resection for non-small cell lung cancer and who have not received chemotherapy or radiation for their disease will be randomly assigned to receive either selenium (a trace mineral) or a placebo (a pill that contains no medicine).

Lymphoma/Lymph Node/Leukemia/Blood-related Cancers

CALGB 10404 A randomized phase II study of three fludarabine/antibody combinations for patients with symptomatic, previously untreated chronic lymphocytic leukemia.

  • Patients who have been diagnosed with chronic lymphocytic leukemia (CLL) and have not had prior treatment may be eligible for this study. Patients would be randomized into one of three groups.

CALGB 9665 CALGB Leukemia Tissue Bank (A Companion Study for CALGB 10404)

  • This is a companion tissue bank for patients enrolled in the CLL trial. It would allow researchers to use samples for additional studies to help evaluate better treatments.

CALGB 50401 A randomized phase II trial of rituximab vs. lenalidomide (revlimid) vs. rituximab + lenalidomide in recurrent follicular non-hodgkin lymphoma (NHL) that is not rituximab-refractory.

  • Patients eligible for this trial would be randomly assigned to receive either lenalidomide or lenalidomide and rituximab. The investigational drug lenalidomide is given orally.

Other Cancers

CALGB 17061: A phase III double blind trial of oral duloxetine for treatment of pain associated with Chemotherapy Induced Peripheral Neuropathy (CIPN).

  • Patients who have peripheral neuropathy (an uncomfortable sensation that occurs mainly in the hands and feet) as a result of their chemotherapy treatment may be eligible for this study. Cymbalta (Duloxetine) is a FDA approved anti-depressant medication (pill) that is also approved for use to treat diabetic neuropathy. As these conditions are similar, it is being evaluated for its effectiveness in treating chemotherapy induced neuropathy.

Prostate Cancer

CTSU S0421 A phase III study of docetaxel and atrasentan versus docetaxel and placebo for patients with advanced hormone refractory prostate cancer.

  • Patients eligible for this trial would be randomly assigned to receive either docetaxel, prednisone and the investigational drug atrasentan or docetaxel, prednisone and a placebo. The investigational drug atrasentan is given orally.

    CALGB 90203 A randomized phase III study of neo-adjuvant docetaxel and androgen deprivation prior to radical prostatectomy versus immediate radical prostatectomy in patients with high-risk, clinically localized prostate cancer.

    • Men who have prostate cancer and are at risk of the cancer returning after surgery to remove their prostate are eligible for this study. The study will compare the effects of hormone therapy and chemotherapy before surgery compared to just surgery alone.

    RTOG 0521 A phase III protocol of androgen suppression(AS) and 3D CRT/IMRT vs AS and 3D CRT/IMRT followed by chemotherapy with docetaxel and prednisone for localized, high risk prostate cancer.

    • Patients with high risk prostate cancer will be randomized to receive either hormone therapy and radiation (the standard treatment) or hormone therapy and radiation, followed by chemotherapy.

    CALGB 9594 Intermittent androgen deprivation in patients with stage D2 prostate cancer, Phase III

    • Men with prostate cancer will receive a combination of hormone drug therapy for seven months. They will then be randomly assigned to continue the treatment or to receive treatment alternating with periods off treatment.

    Where Can I Find Out More?

    American Cancer Society
    National Cancer Institute
    Innisfree Cancer Help
    Cancer Information Service, a toll-free telephone service of the National Cancer Institute 1–800–4–CANCER.

    Last updated 6-2-08