| Trial name | Title of study | Eligibility criteria |
|---|
| Bladder |
| CALGB 90601 | A randomized Double Blind Phase 3 Study comparing Gemcitabine, Cisplatin, and Bevacizumab to Gemcitabine, Cisplatin, and Placebo in patients with advanced transitional cell carcinoma | Metastatic or unresectable transitional cell carcinoma of the urinary tract; may not have received any combination of systemic chemotherapy for met disease |
| Brain |
| CCCWFU 97509 | A phase II Double Blind Feasibility Study of Armodafinil for Brain Induced Fatigue | Primary brain tumor; total of 4500 brain XRT in at least 25 fraction with 150cGY/Fraction planned |
| Breast Cancer, Advanced or Recurrent |
| sysTHER | An observational cohort study of treatment patterns and outcomes in patients with HER2 positive metastatic breast cancer | HER2+MBC within last 6 months; no prior treatment more than 6 months before entry |
| Breast Cancer, Invasive |
| A221102 | Randomized Double Blind Placebo Controlled Study of Subcutaneous testosterone in the adjuvant treatment of post menopausal women with Aromatase inhibitor induced arthralgias | Receiving Anasrozole or letrozole for at least 21 days; BMI between 18 and 32 kg/m2; must have both ER and PR positive tumors and both must be >30% positive; must be postmenopausal > 12 months; > 5 out of 10 arthralgias |
| AMGEN 147 | 147A Randomized Phase 2 study to estimate the
effect of prophylactic intervention with naproxen or loratadine on bone pain in
breast cancer subjects receiving chemotherapy and pegfilgrastim | Female newly diagnosed breast cancer stage 1-3
Adjuvant or neoadjuvant chemotherapy
Creatinine<1.5 ULN
|
| AMGEN 148 | Randomized, single blind study to estimate the
effect of patient education on reported bone pain in breast cancer patients
receiving chemotherapy and pegfilgrastim | Female; newly diagnosed, not previously treated
with chemotherapy, stage I-!! breast cancer; At least 4 cyles of adjuvant or
neoadjuvant chemotherapy; No chronic use of NSAIDS or antihistamines; No
ongoing pain or ongoing steroid use |
| NSABP B49 | A Phase III Clinical Trial Comparing the Combination of Docetaxel plus Cyclophosphamide to Anthracycline-Based Chemotherapy Regimens for Women with Node Positive or High Risk Node Negative Breast Cancer | Female; ECOG 0-1; Unilateral invasive adenocarcinoma of the breast; HER2-negative; Stage: pT1-3; p N0, N1; N2a, pN3a, pN3b;
If pN0 must meet one of the following: ER – and PgR -; Patholgic size >2.0cm or T1c and ER + and either grade 3 or Oncotype Dx score >25
|
| NSABP B47 | A Randomized Phase 3 adjuvant therapy comparing chemotherapy alone (six of AC or four cycles of AC followed by weekly paclitaxel) to chemotherapy plus Trastuzumab in Women with Node Positive or High Risk Node Negative HER 2 Low Invasive Breast Cancer | Female: PS 0-1; Invasive Breast Cancer; pT1-3; pN0, pN1; pN2a, pN2b; pN3a or pN3b; If pN0 must be one of the following :
pTx and ER- and PgR neg
pT2 and ER+ and either grade 3 or Oncotype Dx > 25
Her 2 status evaluated prior to randomization as HER2 low IHC staining of 1+ (ISH testing is not required) or 2+ FISH or CISH must also be performed and must indicate no more than 84 days post op
|
| SWOG S1007 | A Phase 3 Randomized Clinical Trial of Standard Adjuvant Endocrine therapy +/- chemotherapy in pts with 1-3 + nodes, Hormone Receptor + and HER2 negative breast cancer with recurrence Score of 25 or less | Node Positive (1-3); invasive breast cancer; ER+ and/or PR status; HER 2 negative ; must NOT have inflammatory: M0; Oncotype Dx within 28-56 days after definitive surgery; Oncotype Dx if performed before study entry must be 25 or less; PS 0-2 |
| Aphinity (BIG 4-11) | A Randomized multicenter, double blind placebo
controlled comparison of chemotherapy plus trastuzumab plus placebo versus
chemotherapy plus trastuzumab plus pertuzumab as adjuvant therapy in patients
with operable HER-2 positive primary breast cancer | Patients with positive nodes any pT except T0;
for node negative tumor must be > 1.0 cm or 0.5-1.0 cm and at least one of
the following Histologic grade 3 OR Negative for ER and PgR or age <35;
synchronous bilateral invasive disease are eligible as long as both lesions HER
2-positive; 3-7 weeks post op; No T4 or inflammatory lesions |
| Breast Cancer, Prevention |
| CALGB 70806 | Vitamin D and Breast Cancer Biomarkers | DCIS: Her2 Neu positive as determined by central testing; Lumpectomy; No more than 12 days from surgery; must be N0: p N0 (i); pN0 (i+) |
| Colorectal Cancer |
| NSABP P5 | Statin Polyp Prevention Trial in Patients with resectable colon cancer | Stage 1 or 2 adenocarcinoma of the colon; surgically resected with curative intent within 1 year prior to randomization; must be completed adjuvant if planned; colonoscopy within 180 days of randomization |
| CALGB 80702 | A Phase 3 Trial of 6 versus 12 Treatments for Adjuvant FOLFOX plus Celecoxib or Placebo for Patients with Resected Stage 3 colon cancer | Completely resected stage 3 colon cancer; at least one pathologically confirmed positive node; synchronous colon lesions are eligible ; No NSAIDS use at any dose and no aspirin use exceeding 100 mg/day |
| Esophageal Cancer |
| RTOG 1010 | A Phase 2 Trial evaluating the Addition of Trastuzumab to Trimodality Treatment of HER-2 Overexpressing Esophageal Adenocarcinoma | Primary esophageal cancer of the mid, distal, or esophageal junction; Extension into stomach up to 5 cm is allowed; Tissue submitted for HER2 central review; PS 0-2 |
| CALGB 80803 | A randomized Phase II Trial of PET Scan Directed Combined Modality Therapy in Esophageal Cancer | Surgically resectable, adenocarcinoma of the esophagus including the GE junction; EUS staging; T1N1-2 M0 or T2-4, N any; M0 must be detectable FDG uptake on baseline PET/CT Scan of the primary tumor; ECOG 0-1 |
| GYN |
| RTOG 1203 | A Randomized Phase III Study of Standard vs.
IMRT Pelvic Radiation for Post Operataive Treatment of Endometrial and Cervical
Cancer (TIME-C) | Endometrial or cervical cancer within 90 days;
hysterectomy within last 49 days; staging (CT/MRI/PETCT Chest or Abdomen within
90 days); Endometrial with plans for
weekly Cisplatin; <50% of myometrial invasion, gr 3 adenomocarcinom without
uterine serous carcinoma or clear cell histolology; > myometrial invasion
grade 1-2 adenomcarcinoma without USC or clear cell histology Endometrial to be treatment with or without
cisplatin: > 50% myometrial invasion, gr 3 including USC and clear cell
carcinoma, FIGO 2009 stage II endometrial cancer of any grade and IIC1; Cervical
Cancer to be treated with or without weekly cisplatin: 1/3 or more stromal invasiton; lymph vascular
space invasion; large clinical tumor diameter (>4cm) or has the patients
been treated with simple hysterectomy with negative margins and negative nodes
on scans; Cervical cancer to be treated with weekly cisplatin: positive pelvic
nodes resected or microscopic parametrial invasion with negative margins. |
| Head and Neck |
| RTOG 0920 | A Phase 3 Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for locally advanced resected head and neck cancer | Squamous cell of the head and neck (oral cavity, oropharynx, or larynx); Stage T1, N1-2, or T2-3, N0-2, M0 Including no distant mets; Laryngopharygoscopy within 8 weeks; gross total resection of primary tumor with curative intent must be completed within 7 weeks of registration; perineural invasion; lymphovascular invasion; single >3 cm or > 2 lymph nodes (all <6cm); Close Margin; t3 or microscopic T4a primary; T2 oral cavity cancer with 5 mm depth of invasion |
| RTOG 1008 | A Randomized Phase 2 Study of Adjuvant concurrent radiation and chemotherapy versus radiation alone in resected high risk malignant salivary gland tumors | High Grade mucoepidermoid carcinoma; salivary duct carcinoma or high grade adenocarcinoma; Surgically resected within 8 weeks; Pathological Stage T3-4; N1-3; or T1-2, N0 with <1mm positive margin. |
| RTOG 1016 | A Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV Associated Oropharynx Cancer | Pathologically proven Squamous Cell Carcinoma of the oropharynx (tonsil, base of tongue, soft palate, or oropharyngeal walls); Measurable disease; Clinical Stage: T1-2, N2a-N3 or T3-4, any NM); |
| Hepatocellular |
| CALGB 80802 | Phase 3 Randomized Study of Sorfenib plus Doxorubicin versus Sorafenib in patients with Advanced Hepatocelluar Carcinoma | Hepatocelluar carcinoma; Locally advanced or met; measurable disease; no prior adjuvant therapy with sorafenib or Raf/VEGFR inhibitors other prior adj is allowed if completed in > 6 months; no prior systemic therapy for met disease |
| Lab Studies |
| View | Veristrat Observational Study of Patients with Non Small Cell Lung Cancer | Male or female over 18 years of age; Stage IIIB or IV NSCLC that has progressed after at least one standard, first line chemotherapy regimen or not eligible or an appropriate candidate for standard, first line chemotherapy; Has not been previously treated with erlotinib, gefitinib, cetuximab, panitimumab or any investigational agent that target EGFR |
| VMU Research | Clinical Research Sample Collection | Cancer Targeted will change periodically based on sponsor need. |
| PPA | Physicians Plasma Alliance | Blood and urine for patients on monthly listing |
| Lung Cancer, Adjuvant |
| E1505 | A Phase III Randomized Trial of Adjuvant Chemotherapy with or without Bevacizumab for patients with completely resected Stage 1b (>4cm )-IIIA Non small Lung Cancer | Surgery within 6-12 weeks of randomization; chemotherapy at the discretion of the investigator from 3 regimens: Vinorelbine/Cisplatin; Docetaxel/Cisplatin; Gemcitabine/Cisplatin |
| Lung Cancer, Neoadjuvant |
| RTOG 0839 | A Randomized Phase II Study of Preoperative chemoradiotherapy +/- Panitimuab followed by consolidation chemotherapy in potentially operable locally advanced (Stage IIIa, N2) Non Small Cell Lung Cancer | 3A N2+ disease; NSCLC; Diagnosed within 12 weeks of registration; No pleural effusion; FEV1 at least 2.0 |
| Lung Cancer, Non Small Cell |
| G027912 | A Phase II, Double Blind, Placebo Controlled, Randomized Study Evaluating the Safety and Efficacy of Carboplatin/Paclitaxel and Caroplatin/Paclitaxel/Bevacizumab with and without GDC-0941 in patients with previously untreated advanced or recurrent non small cell lung cancer | Untreated stage IV or Recurrent NSCLC; Arms A and B squamous cell and Arms C and D Non Squamous cell; Measurable Disease |
| CALGB 30801 | A Randomized Phase 3 Double Blind trial evaluating Selective COX-2 inhibition in COX-2 expressing Advanced Non Small Cell Lung Cancer | Stage IV and Selected Stage IIIB; No prior treatment; NSCLC |
| E5508 | A Randomized Phase 3 Study of Maintenance Trial with Bevaciuzumab, Pemetrexed or a combination of Bevacizumab and Pemetrexed following Carboplatin, Paclitaxel and Bevacizumab for Adjuvant Non Small Cell Lung Cancer | NSCLC with predominantly squamous cell stage IV; no prior chemo for stage IV; prior adjuvant o’k; no brain mets; measurable or non measurable disease; no cavitary lesions |
| OAM4971G | A Randomized Phase III Multicenter double blind
placebo controlled study evaluating the efficacy and safety or MetMAb in
Combination with Tarceva in patients with MET Diagnostic Positive Non Small
Cell Lung Cancer Who have Received Standard Chemotherapy for Advanced or metastatic
disease | A Randomized Phase III Multicenter double blind
placebo controlled study evaluating the efficacy and safety or MetMAb in
Combination with Tarceva in patients with MET Diagnostic Positive Non Small
Cell Lung Cancer Who have Received Standard Chemotherapy for Advanced or metastatic
disease |
| Lung Cancer, Small Cell |
| CALGB 30610 | A Phase 3 comparison of Thoracic Radiotherapy regimens in patients with limited stage small cell lung cancer also receiving Cisplatin and Etoposide | Limited stage; no contralateral hilar or supraclavicular nodes; no pleural effusion; no pericardial effusion; measurable disease |
| Lymphoma |
| E1411 | Intergroup Randomized Phase II Four Arm Study in Patients > 60 with previously untreated mantle cell mantle lymphoma of therapy with : Arm A = Rituximab + Bendamustine followed by Rituximab Consolidation; Arm B= Rituximab + Bendamustine + Bortezomib followed by Rituximab Consolidation; Arm C= Rituximab + Bendamustine Followed by Lenalidomide + Rituximab Consolidation or Arm D= Rituximab + Bendamustine + Bortezomib followed by Lenalidomide + Rituximab Consolidation | Mantle cell lymphoma with documented with cyclin D1 by IHC stains and/or t (11;14) by cytogenetics or FISH; At least one objective measurable disease parameter within 4 weeks of registration |
| Melanoma |
| E1609 | A Phase III Randomized Study of Adjuvant Ipilimumab Anti-CTLA4 therapy versus high dose Interferon a-2b for Resected High Risk Melanoma | Completely resected with the following stages: IIIB, IIIC, IV
Stage IV must have normal LDH and wither distant skin, subcutaneous, lymph node or lung mets, but no other visceral melanoma; Patients with disease recurrence after adequate surgical excision of the original primary cutaneous melanoma are allowed as follows:
Recurrence in a regional node basin after prior complete lymph node dissection. Relapsed disease must be completely surgically resected with free margins
Recurrence in the form of in-transit or satellite mets or distant skin/subcutaneous, nodal or lung mets that are completely surgically resected with free margins
Recurrence in a regional lymph node basin. Relapsed disease has been completely surgically resected with free margins;
Patients with unknown primary melanoma who presents with cutaneous, subcutaneous, nodal and/or lung mets that are completely surgically resected with free margins are allowed.
|
| Mesothelioma |
| SWOG S0905 | A Phase I Randomized Phase II Study of Cediranib Versus Placebo in Combination with Cisplatin and Pemetrexed in Chemonaive Patients with Malignant Pleural Mesothelioma | Malignant pleural mesothelioma; measurable or non measurable disease; must not have received prior systemic therapy; May have had surgery and radiation if greater than 28 days; PS 0-2 |
| Multiple Myeloma |
| ECOG E3A06 | Randomized Phase III trial of Lenalidomide
Versus Observation Alone in Patients with Asymptomatic High Risk Smoldering
Multiple Myeloma | Asymsptomatic high risk smoldering Multiple
myeloma within past 12 months as confirmed by bone marrow plasmacytosis with >10 % plasma cells or sheets of plasma
cells within last 4 weeks; Abnormal serum free light chain ratio (,0.125 or
>8.0) by serum FLC assay; must have measurable levels of M protein; No lytic lesions on skeletal
surveys and no hypercalcemia |
| Prostate |
| RTOG 1115 | Phase III Trial of Dose Escalated Radiation and standard androgen deprivation therapy (ADT) with GNRH Agonist vs. Dose Escalated Radiation Therapy and enhanced ADT with GNRH Agonist and TAK-700 for men with high risk prostate cancer | Adenocarcinoma of the prostate within 180 days prior to registration; clinically negative nodes within 90 days by imaging; M0; No testosterone within 90 days.
High Risk:
Gleason Score > 9 and PSA < 150 and Any T stage
Gleason Score 8 and PSA < 20 and T stage > T2
Gleason Score 8 and PSA > 20-150 and Any Stage
Gleason Score 7 and PSA > 20-150 and Any T Stage
No prior Hormonal Therapy estrogens or surgical castration; No prior radiation therapy
|
| RTOG 0924 | 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 | Diagnosis within 180 days: moderate to high risk:
Gleason score 7-10 + T1c-T2b+PSA<50
Gleason Score 6+T2c-T4 or >50% positive biopsies+PSA<50
Gleason Score + T1c-T2b +PSA >20
No prior surgery, radiation, hormone ablation
|
| RTOG 0815 | A Phase 3 prospective randomized trial of dose escalated radiotherapy with or without Short term Androgen deprivation therapy for patients with intermediate risk prostate cancer | Prostate cancer in the last 6 months; intermediate risk by one or more of the following: Gleason Score 7; PSA> 10 by<20; Clincial Stage t2b-T2c; clinically negative lymph node; PS 0-1 |
| SWOG S1014 | Abiraterone Acetate Treatment for prostate cancer patients with rising PSA of more that four following initial androgen deprivation therapy, Phase II | Adenocarcinoma of the prostate; must have M1 disease; Must be receiving androgen deprivation therapy prior to entering; Suboptimal response to ADT (declining PSA that fails to reach 4 ng/ml; the PSA must be observed between 6-9 months after the intitation of ADT; Rising PSA and progressive disease are not eligible |
| RTOG 0534 | A Phase 3 trial of short term androgen deprivation with pelvic node or positive bed only radiotherapy (SPORT) in prostate cancer patients with rising PSA after radical prostatectomy | Adenocarcinoam of the prostate with radical prostatectomy, N0 or Nx; Post op PSA >0.2 and <2.0; T3N0/Nx; Gleason Score 8 or less; no prior radiation |
| CALGB 90203 | A randomized Phase 3 study of Neoadjuvant Docetaxel and Androgen deprivation prior to radical prostatectomy versus immediate radical prostatectomy in patients with high risk clinically localized prostate cancer | Adenocarcinoma of the prostate; clinically localized disease (T1-3a) and no radiographic evidence of met disease; nomogram predication of 60%; No prior treatment for prostate cancer including surgery (TURP), pelvic node dissection, radiation, or chemotherapy; may have received up to 3 months ADT |
| Renal Cell Carcinoma |
| EVEREST SWOG S0931 | Everolimus for Renal Cancer ensuing surgical therapy, A Phase III Study | Renal cell carcinoma with intermediate or high risk; Undergone Full Resection; Bilateral renal tumors are not eligible |
| CALGB 90802 | Randomized Phase III Trial comparing Everolimus
plus Placebo versus Everolimus plus Bevacizumab for advanced renal cell
carcinoma progressing after treatment with Tyrosine Kinase Inhibitor | Renal cell carcinoma with some clear cell
histology; metastatic or unresectable; Must have had at least 1 prior VEGFR
tyrosine kinase inhibitor and have progressed or have been intolerant to
treatment; ; prior cytokine is allowed; no prior treatment with mTOR inhibitor;
no active brain mets; no DVT or PE |
| E2810 | Randomized, Double Blind Phase III Study of
Pazopanib vs. Placebo in Patients with Metastaitc Renal Cell Carecinoma who
have no evidence of Disease Following Metastatectomy | Renal cell carcinoma with clear cell
componenet;pure papillary and
chromophne histologies are excluded; must have underone nephrectomy or partial
nephrectomy; must have undergone surgical resection to remove one or mor sites
of metastatic disease with successful removal of all known sites 2-12 weeks
prior to randomization; No evidence of disease on post operative imaging CT
and.or MRI conducted withine 4 weeks prior to randomization |
| Survival and Quality of Life |
| VCU Day and Night Study | (Norton Cancer Center Only) Day and Night Study of Lifestyle and Cancer Survival Study | Age: 18-70; Male or female; Stage I or II Lung Breast Colorectal or prostate cancer; At least 6 months since end of treatment (taking hormones still ok) Concurrent malignancies o’k as long as both stage I or II. No maximum since diagnosis |
| N08C9 | (Opening August 2012) Phase III, Randomized, Study of Sulfasalazine versus Placebo in the Prevention of Acute Diarrhea in Patients Receiving Pelvic Radiation Therapy | Ability to complete questionnaires; life expectancy of 6 months; diagnosis of cancer that supports radiation to the pelvis with minimum dose of 4500cGy with or without 5FU, Capecitabine or Oxaliplatin is planned. Not receiving Leucovorin. |
| 99311 | Randomized Placebo Controlled Phase 2 Pilot
Study of Memantine for Smoking Cessation among Cancer Survivors | Stage I or II NSCLC or non metastatic breast
prostate or colorectal; 6 months post definitive treatment; Smoked 100
cigarettes over lifetime and who, at the time of first interview , smoked 10 or
more cigarettes per day on most days over past month |
| A221102 | Randomized Double Blind Placebo Controlled Study
of Subcutaneous testosterone in the adjuvant treatment of post menopausal women
with Aromatase inhibitor induced arthralgia | Receiving Anasrozole or letrozole for at least
21 days; BMI between 18 and 32 kg/m2; must have both ER and PR positive tumors
and both must be >30% positive; must be postmenopausal > 12 months; >
5 out of 10 arthralgia |
| AMGEN 147 | 147A Randomized Phase 2 study to estimate the
effect of prophylactic intervention with naproxen or loratadine on bone pain in
breast cancer subjects receiving chemotherapy and pegfilgrastim | female newly diagnosed breast cancer stage 1-3
Adjuvant or neoadjuvant chemotherapy
Creatinine<1.5 ULN
Planning on receiving at least 4 cycles of chemotherapy
Planning on receiving prophylaxis with pegfilgrastim
No ongoing chronic pain issues
No chronic use of NSAIDS or antihistamines |
| AMGEN 148 | Randomized, single blind study to estimate the
effect of patient education on reported bone pain in breast cancer patients
receiving chemotherapy and pegfilgrastim | Female; newly diagnosed, not previously treated
with chemotherapy, stage 1-3 breast cancer; At least 4 cyles of adjuvant or
neoadjuvant chemotherapy; No chronic use of NSAIDS or antihistamines; No
ongoing pain or ongoing steroid use |