CLINICAL RESEARCH at Salem Hospital
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Summary of Open Oncology Protocols
For more information contact Oncology Clinical Research at (503) 561-2618.
Select Oncology Protocol Site:
Site: Brain
Protocol: RTOG 0525
Title Phase III Trial
Comparing
Conventional
Adjuvant
Temozolomide with
Dose-Intensive
Temozolomide in
Patients with Newly
Diagnosed
Glioblastoma
Treatment **Will close to patient enrollment on June 13, 2008 because it is anticipated to have met the accrual objective by that time.
Patient is registered to study and receives Radiation (60 Gy in 2 Gy fractions) and concurrent daily Temozolomide (every day for 49 days). During this period, tissue is submitted for evaluation to RTOG.
After initial treatment, patient is then randomized to either ARM 1: (standard therapy) Temozolomide days 1-5 of a 28 day cycle. For a total of 6 cycles*.
Treatment Arm 2: Temozolomide days 1-21 of a 28 day cycle. For a total of 6 cycles*.
* up to 12 cycles may be given if the patient demonstrates continued improvement on MRI, decrease in steroids, improvement in neurologic function and p. status.
Eligibility **Will close to patient enrollment on June 13, 2008 because it is anticipated to have met the accrual objective by that time.
Histologically proven Glioblastoma. Must have 1 block tissue available for MGMT analysis. Tumor must have supratentorial component. Preop & postop enhanced MRI/CT required. Treatment to begin within 5 weeks of surgery. Patient recovered from surgery. Performance Status = 60%.
Site: Breast
Protocol: ECOG E5103
Title 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
Treatment STEP 1: Arm A:AC X 4 +Placebo Q14 or 21 days X 4 followed by Paclitaxel q week X 12 +Placebo Q 21 days X 4
ARM B:AC X 4 + Bev q 14 or 21 days X 4 followed by Paclitaxel q week X 12 + Bev q 21 days X 4
ARM C:AC X 4 +Bev q 14 or 21 days X 4 followed by Paclitaxel q week X 12 +Bev q 21 days X 4
STEP 2: Arm D-Prior ARM C Patients ONLY: Bevacuzumab Q 21 days X 10
Eligibility Histologically confirmed adenocarcinoma of the breast at significant risk of distant recurrence based on at least one of the following: Involvement of 1 lymph node on routine histologic exam; ER negative >/= 1 cm; ER+ tumor >/+ 5 cms regardless of recurrence score; ER+ tumor >/= 1 cm < 5 cm with recurrence score of >/= 11(may also be enrolled in the TailorX Trial); Completed definitive breast surgery; Margins histologically free of IBC or DCIS(LCIS allowed); Must start tx between day 28 and 84 from surgery;Must have RT if undergone BCS or undergone mastectomy with tumor > 5 cm or 4+ LNs; No HER2+; No inflammatory or fixed LNs at diagnosis; No Prior Chemo/Hormonal therapy for this breast cancer; No prior anthracycline, anthracenedione or taxane; Prior use of tamoxifen(prevention) and raloxifine must be discontinued at study entry
Protocol: ECOG PACCT1
Title Phase III Randomized
Study of Adjuvant
Combination
Chemotherapy and
Hormonal Therapy vs
Adjuvant Hormonal
Therapy Alone in
Women With
Previously Resected
Axillary
Node-Negative
Breast Cancer With
Various Levels of
Risk for Recurrence
(TAILORx Trial)
Treatment Based on Oncotype DX Assay score: Arm A: Hormonal Therapy; Arm B: Hormonal Therapy; Arm C: Chemotherapy and Hormonal Therapy; Arm D: Chemotherapy and Hormonal Therapy. Patients who have had breast conservation surgery must have Radiation Therapy.
Eligibility ER Positive and/or PR Positive. Axillary Node Negative. Candidate for adjuvant cytotoxic therapy in addition to hormonal therapy.
Protocol: NSABP B 39 / RTOG 0413
Title A Randomized Phase
III Study of
Conventional Whole
Breast Irradiation
(WBI) vs Partial
Breast Irradiation
(PBI) for Women
with Stage 0, I, or
II Breast Cancer
Treatment Group 1: Whole Breast Radiation Therapy 45 - 50 Gy in 25 fractions, followed by optional boost.
Group 2: Partial Breast Radiation Therapy 38.5 Gy in 3.85 Gy fractions using 3D conformal external beam radiation.
Eligibility Stage 0, 1, or 2 breast cancer. If stage 2, tumor size must be <3cm. Clear margins. No more than 3 histological positive axillary nodes. Women who are >50 with DCIS only, or over 50 with invasive, node neg and hormone positive are not eligible.
Protocol: NSABP B-42
Title A Clinical Trial to
Determine the
Efficacy of 5 Years
of Letrozole vs
Placebo in Patients
Completing 5 Years
of Hormonal Therapy
Consisting of an AI
or Tamoxifen
Followed by an AI
in Prolonging
Disease-Free
Survival in
Post-menopausal
Women with Hormone
Receptor Positive
Cancer.
Treatment Group 1: Placebo taken orally once daily for 5 years.
Group 2: Letrozole 2.5 mg taken orally once daily for 5 years.
Eligibility Postmenopausal. Pathologic or clinical stage I, II, IIIA. ER and/or PgR positive. Hormonal therapy must have consisted of an AI or a combo of up to 3 years Tamoxifen followed by an AI. Tamoxifen may not have been given during years 4 & 5 of adjuvant hormonal therapy.
Protocol: Optional with NSABP B-42
Title OPTIONAL NSABP B-42
REGISTRATION
PROGRAM: To Provide
Up to Three Years of
Letrozole to
Postmenopausal
Women with Hormone
Receptor Positive
Breast Cancer Who
Have Received at
Least Two Years of
Initial Adjuvant
Hormonal Therapy
Treatment Letrozole 2.5 mg taken orally once daily until completion of 57 - 63 months of initial adjuvant therapy.
Eligibility Postmenopausal. Stage I, II, IIIA invasive cancer. ER and/or PgR positive. Must be currently taking AI or Tamoxifen. Must have received a minumum of 2 years but not more than 4.5 years of initial adjuvant hormonal therapy. Total duration of tamoxifen must not exceed 3 years.
Protocol: SWOG S0230
Title Phase III Trial of
LHRH Analog
Administration
during Chemotherapy
to Reduce Ovarian
Failure following
Chemotherapy in
Early Stage,
Hormone-Receptor
Negative Breast
Cancer
Treatment Treatment Arm 1: Standard Adjuvant Chemotherapy
Treatment Arm 2: Standard Adjuvant Chemotherapy with Goserelin. Goserlin is given once every 4 weeks during chemotherapy.
Eligibility Operable stage I, II, or IIIA invasive breast cancer. Tumors must be ER & PR negative. Must be premenopausal. Must have modified radical mastectomy or local excision plus axillary lymph node dissection and/or sentinel node. Planned treatment must include 3-8 cycles of chemotherapy.
Site: Breast Implant
Protocol: Mentor Silicone Gel-Filled
Title Mentor Silicone
Gel-Filled Mammary
Prosthesis Clinical
Research Study
Treatment
Eligibility
Site: Cervical
Protocol: GOG 0219
Title A Phase III
Randomized Trial of
Weekly Cisplatin and
Radiation vs
Cisplatin and
Tirapazamine and
Radiation in Stage
IB2, IIA, IIB,
IIIB, and IVA
Cervical Carcinoma
Limited to the
Pelvis
Treatment Arm 1: Cisplatin 40mg/m2(max=70 mg) IV over 1 hour weekly X 6 cycles with concurrent Radiation Therapy.
Arm 2: Cisplatin 75 mg/m2 (max=140 mg)IV over 1 hour, days 1,15,29. Tirapazamine 290 mg/m2 (max=385mg) IV over 2 hours days 8,10,12,22,24,26 concurrent with Radiation Therapy X 6 cycles.
Eligibility Patients with primary, untreated histologically confirmed invasive squamous, adeno, or adenosquamous of the cervix. Stages IB2, IIA, IIB, and IVA. Must have negative, non-suspicious para-aortic nodes. Stage IIIA (lower one-third vaginal involvement) are not eligible.
Site: CML
Protocol: CSTI571A2402
Title A Worldwide,
Observational
Registry collecting
Longitudinal Data on
the Management of
Chronic Myelogenous
Leukemia (CML)
Patients (The WORLD
CML Registry) in
Routine Practice
Treatment Not a treatment protocol
Eligibility Diagnosed with any phase ph+ or bcr-abl confirmed CML within 6 months of entry into the Registry. Provided informed consent.
Site: Colon
Protocol: ECOG E5202
Title Randomized Phase III
Study Comparing
FOLFOX Chemotherapy
vs. FOLFOX
Chemotherapy with
Bevacizumab in
Patients with Stage
II Colon Cancer at
High Risk for
Recurrence to
Determine
Prospectively the
Prognostic Value of
Molecular Markers
Treatment Based on tumor block risk assessment: High risk patients are randomized to Arm A or Arm B. Low risk patients are on Arm C.
Arm A: FOLFOX every 2 weeks for a total of 12 cycles.
Arm B: FOLFOX plus Bevacizumab every 2 weeks for 12 cycles. Then Bevacizumab alone every 2 weeks for 12 cycles.
Arm C: Observation.
Eligibility Histologically confirmed adenocarcinoma of the colon that is Stage II (T3,4 NO,MO). Distal extent of tumor must be >/= 12 cm from the anal verge as determined via endoscopy or surgery. Patients must have >/= 8 lymph nodes evaluable and reported. Patients must have paraffin-embedded tumor specimen available for central evaluation and risk assessment. No isolated, distant, or intra-abdominal mets. Patients must not have presented with complete obstruction or perforation of the bowel. No prior radiation therapy for this malignancy. Must have post-operative evidence of adequate hepatic and renal function.
Protocol: NCCTG N0147
Title Randomized Phase II
Trial of
Oxaliplatin Plus
5-FU/Leucovorin
(FOLFOX) with or
without Cetuximab
after Curative
Resection of
Patients with Stage
III Colon Cancer
Treatment Arm A: FOLFOX - Give twelve 14 day cycles.
Arm D: FOLFOX plus Cetuximab - give twelve, 14 day cycles.
Eligibility Histologically documented adenocarcinoma of the colon that has been completely resected. At least 1 pathologically confirmed positive lymph node identified. No evidence of residual lymph node disease. Randomization must occur <56 days post surgery. Patients with > one synchronous primary colon cancer are eligible. Performance Status 0-2. No distant metastatic disease and no prior chemo or radiation therapy. Patients with certain cardiac conditions are ineligible.
Protocol: SWOG C80405
Title 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
Treatment Arm A: Bevacizumab 5mg/kg IV every 2 weeks followed by FOLFOX or FOLFIRI every 2 weeks. ARM B: Cetuximab 400 mg/m2 IV Day 1 of cycle 1 then 250 mg/m2 IV weekly followed by FOLFOX or FOLFIRI every 2 weeks. ARM C: same as Arm B plus Bevacizumab 5mg/kg.
Eligibility Histologically or cytologically confirmed, locally advanced or metastatic colorectal cancer. No prior treatment unless adjuvant given with 5-FU, oxal, or irino. No prior VEGF or EGF treatment. No significant peripheral neuropathy. No prior Cetuximab or Bevacizumab.
Site: Gastric / GE Junction
Protocol: C80101
Title Phase III Intergroup
Trial of Adjuvant
Chemoradiation
After Resection of
Gastric or
Gastroesophageal
Adenocarcinoma
Treatment ARM A: Cycles 1,3,4: Leucovorin + 5-FU given on days 1 through 5, every 28 days.
Cycle 2: Continuous infusion of 5-FU + Radiation Therapy lasting approximately 5-6 weeks.
ARM B: Cycle 1: ECF - Epirubicin + Cisplatin given on day 1; 5-FU continuous infusion given on day 1 through day 21.
Cycle 2: Continuous infusion of 5-FU + Radiation Therapy lasting approximately 5-6 weeks.
Cycle 3,4: ECF - reduced rate of Epirubicin + Cisplatin given on day 1; 5-FU continuous infusion given on day 1 through day 21.
There will be no interruption of infusional 5-FU between cycles 3 and 4. Cycle 3 will end on day 21, Cycle 4 will begin on day 22.
Eligibility Histologically diagnosed adenocarcinoma of stomach or gastroesophageal junction.Patients must have had en bloc resection of all known tumor with curative intent.Patients must have tumor extension beyond muscularis propria and/or nodal involvement. No known unresected tumor, recurent cancer, microscopic evidence of tumor at the distal or proximal line of stomach rescetion, or noncontiguous resection allowed. No M1 disease. No previous chemo, or RT. Patient must have stable weight for at least one week prior to registration. Must be evaluated by a radiation oncologist.
Site: Lung
Protocol: ECOG E1505
Title A Phase III
Randomized Trial of
Adjuvant
Chemotherapy With
or Without
Bevacizumab for
Completely Resected
Stage IB-IIIA
Non-Small Cell Lung
Cancer (NSCLC)
Treatment Arm A: 1 of 3 chemotherapy regimens; no bevacizumab
Arm B: 1 of 3 chemotherapy regimens,PLUS bevacizumab 15 mg/kg IV delivered immediately after completion of chemotherapy for the first 4 cycles. Then bevacizumab will continue every 3 weeks for up to 1 year.
Eligibility Complete resection of Stage 1B (>4cm)- IIIA non-small cell lung cancer. Wedge resection or segmentectomy will not be accepted. Lymph node sampling is expected. Refer to protocol for specifics. Patients must be no less than 6 weeks and no more than 12 weeks post-thoracotomy at the time of randomization and must be adequately recovered fom surgery. Performance status 0 or 1. No prior chemo allowed. Hormonal therapy or radiation therapy as prior cancer treatment within 5 years of randomization for a malignancy over 5 years that is now considered cured is acceptable. No myocardial infarction within 12 months. Patients with any history of cerebral vascular accident (CVA) or transient ischemic attack (TIA)will not be allowed on trial. Patients with on-going post-operative hemoptysis are not eligible. Pre-operative hemoptysis that has resolved post-operatively are eligible.
Protocol: SWOG S9925
Title Lung Cancer Specimen
Repository Protocol,
Ancillary
Treatment Specimen repository.
Eligibility Must be registered to a treatment protocol: S0536; S0424
Site: Lymphoma
Protocol: SWOG 8947
Title Central Lymphoma
Serum Repository
Protocol
Treatment Serum repository.
Eligibility Must be registered to a treatment protocol.
Protocol: SWOG 9245
Title Central Lymphoma
Repository Tissue
Procurement
Protocol for
Relapse or
Recurrent Disease
Treatment Specimen repository.
Eligibility Must be registered to a treatment protocol: 8410; 8503; 8508; 8516; 8736; 8809; 8907; 8954; 9125; 9240; 9320; 9349; 9432; 9501; 9703; S9704; 9800
Protocol: SWOG S0515
Title Phase II Trial of
Standard Dose CHOP
and Rituximab plus
Bevacizumab for
Advanced Stage
Diffuse Large
B-Cell
Non-Hodgkin's
Lymphoma
Treatment Cyclophosphamide 750mg/m2 IV Day 1
Vincristine 1.4mg/m2 IV Day 1
Doxorubicin 50mg/m2 IV D1
Prednisone 100mg orally Days 1-5
Rituximab 375mg/m2 IV Day 1
Bevacizumab 15mg/kg IV Day 1
every 21 days X 8 cycles
Eligibility Previously untreated Stage III, IV or bulky Stage II diffuse large B-cell NHL. Must be CD20 positive. Performance Status 0-2. Ejection Fraction >/=45%. MUGA/ECHO within normal limits. Bi-dimensional measurable disease. Uni/Bilat bone marrow aspiration and biopsy.
Site: Melanoma
Protocol: ECOG E1Y03
Title Pharmacogenetic and
Genomic Studies -
In association with
E2603
Treatment Not a treatment protocol.
Eligibility Must be registered to a treatment protocol: E2603.
Protocol: SWOG E1697
Title Phase III Randomized
Study of Four Weeks
High Dose IFN-a2b
in Stage T2bNo,
T3a-b, T4a-bNo, and
T1-4, N1a,2a,3
(microscopic)
Melanoma
Treatment Arm A: Observation vs. Arm B: Interferon a2b IV over 20 minutes, five times each week for four weeks.
Eligibility Melanoma of a cutaneous orgin. Stage T2bNo, T3a-b, T4a-bNo, and T1-4, N1a,2a,3. Patients must complete all primary therapy (wide exicision with or without lymphadenectomy) and be randomized within 84 days of their wide excision. No prior chemotherapy, radiotherapy, or immunotherapy for melanoma allowed.
Site: Myeloma
Protocol: CZOL466GUS135T
Title Factors that
Determine Overall
Survival among
Patients with
Multiple Myeloma
Treated with
Zoledronic Acid
Treatment Retrospective chart review. Not a treatment study.
Eligibility Must have diagnosis of Multiple Myeloma. Treatment with at least one treatment of Zolodronic Acid(Zometa). No other malignancies
Site: Prostate
Protocol: OHSU 2734
Title A Randomized Phase
II Study of
Intermittent
Chemotherapy or
Intermittent
Chemotherapy with
Maintenance GM-CSF
in Patients with
Previously
Untreated
Metastatic Hormone
Refractory Prostate
Cancer
Treatment Study Enrollment: Induction chemo X 6 cycles Doxetaxel 75 mg IV day 2 + Prednisone 5 mg po bid days 1-21 q 21 days:If there is a decline in PSA by greater than or equal to 50% then Randomization occurs:
Randomization:
Arm 1: Observation-to be evaluated every 28 days, ir progression then reinitiate chemo X 6 cycles: As long as PSA decreases by greater than or equal to 50% patient goes back on observation:
ARM 2: GM-CSF--250mcg/m2 SQ Days 15-28 q 28 days. This continues until progression, once progression occurs reinitiation on chemo X 6 cycles. As long as PSA decreases by greater than or equal to 50% patient goes back on GM-CSF.
After reinitiation of chemo, patient must demonstrate a decrease greater than or equal to 50% AND RECIST-defined stable disease or better.
Eligibility Previously Untreated Metastatic Hormone Refractory Prostate Cancer
Protocol: RTOG 0521
Title Phase III Protocol
of Androgen
Suppression (AS)
and 3DCRT/IMRT vs
AS and 3DCRT/IMRT
followed by
Chemotherapy with
Docetaxel and
Prednisone for
Localized,
High-Risk Prostate
Cancer
Treatment Treatment Arm 1: AS (LHRH agonist and oral antiandrogen) X 8 weeks followed by Radiation Therapy to 72.0 - 75.0 Gy with concurrent AS. LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of radiotherapy.
Treatment Arm 2: AS (LHRH agonist and oral antiandrogen) X 8 weeks followed by Radiation Therapy to 72.0 - 75.0 Gy with concurrent AS. LHRH will continue for a total of 24 months from initiation of any treatment. Oral antiandrogen will be discontinued at the end of RT. PLUS 6 cycles of docetaxel and prednisone delivered concurrently with androgen suppression beginning 28 days after completion of RT: Docetaxel IV over 1 hour on day 1 of each cycle every 21 days. Premedication for docetaxel with dexamethasone is required. PLUS Oral Prednisone daily until day 21 of the last cycle of chemotherapy.
Eligibility Histologically confirmed prostate cancer within 180 days prior to registration. Pretreatment serum PSA obtained prior to any LHRH or antiandrogen therapy. Prior 5-alpha reductase inhibitor (finasteride) for prostatic hypertrophy is allowed if discontinued at least 60 days prior to registration. Prior testosterone administration is allowed if last administered at least 90 days prior to registration. Prior pharmacologic androgen ablation for prostate cancer is allowed only if the onset of androgen ablation is < = 50 days prior to the date of registration. INELIGIBILTY: PSA > 150. Evidence of M1 disease. Positive lymph nodes or nodes > 1.5 cm on imaging. Prior radical prostatectomy, cryosurgery, bilateral orchiectomy, malignancy, systemic chemotherapy, radiotherapy including brachytherapy. Severe, active co-morbidity such as unstable angina or CHF requiring hospitalization with the last 6 months. Prior MI with the last 6 months. Existing neuropathy > grade 2.
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