For more information contact Oncology Clinical Research at 503-561-2618.
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 every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Placebo every 21 days X 4
ARM B: AC X 4 + Bev every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Bev every 21 days X 4
ARM C: AC X 4 + Bev every 14 or 21 days X 4 followed by Paclitaxel every week X 12 + Bev every 21 days X 4
STEP 2: Arm D: Prior ARM C Patients ONLY: Bevacuzumab every 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: S0622
Title
Phase II Studies of
Two Different
Schedules of
Dasatinib
(NSC-732517) in
Bone-Metastasis
Predominant
Metastatic Breast
Cancer
Treatment
Treatment Arm 1: Dasatinib 100 mg daily, by mouth.
Treatment Arm 2: Dasatinib 70 mg twice daily, by mouth.
Eligibility
Women or men with Stage IV breast cancer which is bone-predominant.
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.
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.
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: R0436
Title
A Phase III Trial
Evaluating the
Addition of
Cetuximab to
Paclitaxel,
Cisplatin, and
Radiation for
Patients with
Esophageal Cancer
Who are Treated
Without Surgery
Treatment
Pending IRB Approval September 2008
Treatment Arm 1: Radiation Therapy + Paclitaxel + Cisplatin + Cetuximab
Treatment Arm 2: Radiation Therapy + Paclitaxel + Cisplatin
Eligibility
Pending IRB Approval September 2008
Histologically proven diagnosis, via endoscopy, of primary squamous cell or adenocarcinoma of the esophagus or gastroesophageal junction within 6 weeks of registration. All disease must be encompassed in the radiotherapy field. Stage T1N1MO; T2-4,Any N, MO; Any T, Any N, M1a. Patient's total caloric intake must be at least 1500 calories a day. No evidence of tracheoesophageal fistula or invasion into the major bronchi. No prior chemotherapy for esophageal cancer.
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.
Protocol: S0502
Title
A Phase III
Randomized Study of
Imatinib, with or
without Bevacizumab
(NSC-704865), in
Patients with
Metastatic or
Unresectable
Gastrointestinal
Stromal Tumors
Treatment
Treatment Arm 1: Imatinib orally every day plus bevacizumab IV every three weeks.
Treatment Arm 2: Imatinib orally every day.
Eligibility
Biopsy proven GIST that is distantly metastatic or unresectable. Measurable and/or non-measurable disease. May have received traditional chemo agents. At least 28 days since completion. No prior imatinib, bevacizumab, or other agents targeting KIT, VEGF, VEGFR, or PDGFR for advanced disease. Those agents may have been used in the adjuvant setting if patient did not recur for at least 12 months following therapy. Prior RT allowed if 28 days post.
Protocol: LORHAN Registry
Title
Prospective,
Longitudinal,
Multi-Center,
Descriptive
Registry of
Patients Receiving
Therapy other than
Surgical Resection
Alone for Newly
Diagnosed Head and
Neck Carcinoma.
Treatment
Not a treatment protocol.
Eligibility
Histologically or cytologically confirmed new diagnosis of carcinoma involving the oral cavity, oropharynx, nasopharynx, hypopharynx, larynx, or neck node metastasis from unknown origin. Scheduled to receive radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy. Written informed consent. Registry participation does not exclude participation in clinical trials. Patients scheduled to receive, or who have received surgery, are eligible for registry participation as long as they are also scheduled to receive medical therapy.
Protocol: C30607
Title
Randomized, Phase
III,
Placebo-Controlled
Trial of Sunitinib
as Maintenance
Therapy in
Non-Progressing
Patients Following
an Initial Four
Cycles of
Platinum-Based
Combination
Chemotherapy in
Advanced, Stage
IIIB/IV Non-Small
Cell Lung Cancer
Treatment
Pending IRB Approval August 2008
Blinded Treatment - will be unblinded at time of progression.
Treatment Arm A: Sunitinib 37.5 mg (three 12.5 mg capsules) orally once daily until disease progression or intolerable toxicity.
Treatment Arm B: Placebo (three capsules) orally once daily intil disease progression or intolerable toxicity.
Eligibility
Pending IRB Approval August 2008
Histologic or cytologic stage IIIB or IV NSCLC. No brain mets or spinal cord compression. Patients must have received 4 cycles of platinum-based doublet therapy with or without bevacizumab. No evidence of disease progression. No prior adjuvant chemo for stage I-III resected or combined modality therapy for stage III NSCLC. Cardiac restrictions apply.
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
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.
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: S0438
Title
A Randomized Phase
II Trial of Bay
43-9006 (Sorafenib;
NSC-724772) With
Either CCI-779
(Temsirolimus;
NSC-683864) or
R115777
(Tipifarnib;
NSC-702818) in
Metastatic Melanoma
Treatment
Treatment Arm 1: Bay 43-9006 (sorafenib) orally, twice daily continuously and IV CCI-779 (temsirolimus) given weekly.
Treatment Arm 2: Bay 43-9006 (sorafenib) orally, twice daily continuously and R115777 (tipifarnib) orally, daily for 3 weeks followed by 1 week of rest.
Eligibility
Biopsy proven malignant melanoma of cutaneous or mucosal orgin. Patients with ocular melanoma are not eligible. Patients must have unresectable disease. Patients must have Stage IV disease. Must have measurable disease. Must have negative CT/MRI of brain within 42 days of registration. No prior systemic therapy for Stage IV disease. Prior adjuvant therapy is allowed and may include cytoxic agents, but the interval from most recent exposure until registration must be at least 90 days. Prior RT is allowed if completed at least 28 days prior to registration. Adequate labs.
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.
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 within current treatment field. 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.
Protocol: E2805
Title
Adjuvant Sorafenib
or Sunitinib for
Unfavorable Renal
Carcinoma
Treatment
Pending IRB Approval August 2008
Treatment Arm A: Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles AND placebo for Sunitinib 400mg orally twice daily for 6 weeks for 9 cycles.
Treatment Arm B: Sorafenib 400mg orally twice daily for 6 weeks for 9 cycles AND Placebo for Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles.
Treatment Arm C: Placebo for Sorafenib 400mg orally twice daily for 6 weeks for 9 cycles AND Placebo for Sunitinib 50mg orally daily for 4 weeks followed by 2 weeks of rest for 9 cycles.
Eligibility
Pending IRB Approval August 2008
Patients with histological or cytological confirmed RCC T1B, T2, T3 and T4 with any N. Patients must have undergone full surgical resection - radical or partial nephrectomy by either open or laparoscopic technique, with clear margins. Positive regional LNs require regional lymphadenectomy. Patients must not have CT or MRI evidence of residual or metastatic disease. Must have tumor specimen available for specimen submission. Must not have collecting duct or medullary carcinoma. No prior anticancer treatments for RCC either in the adjuvant or neoadjuvant setting. Patients must be 3-10 weeks post surgery at randomization in order to begin protocol treatment 4-12 weeks from surgery.
