BREAST PROTOCOLS: Neoadjuvant

1.  ACOSOG Z1031 (temporarily closed to accrual)
Neoadjuvant Hormonal Therapy
Eligibility: clinical stage T2-T4c, any N, M0; ER+ tumor with Allred score of 6, 7 or 8; postmenopausal; surgical resection is the goal; performance status 0-2: RX: Exemestane 25 mg/day vs Letrozole 2.5 mg/day vs Anastrozole 1
mg/day. Pts will have breast biopsy at 2-4 wks for Ki67 testing. Pts with Ki67 of </=10 will continue AI for total of 16-18wks followed by surgery. Pts with Ki67 >10 will have chemo or immediate surgery. (NO DRUG SUPPLIED)

2. CALGB 40601
Clinical Stage II-III; HER2 Positive
Eligibility: breast tumor must be at least 1 cm by clinical  or radiographic msmt; multicentric or bilateral dz is OK; no prior treatment for this cancer; performance status 0-1; men OK: Rx: Taxol/Herceptin weekly + Lapatinib po qd x 16 weeks versus Taxol/Herceptin weekly x 16 weeks. (LAPATINIB SUPPLIED) Companion study: SCUSF 0806 (with Herceptin).

3. CALGB 40603 (temporarily closed to accrual)
Clinical Stage IIA-IIIA; Triple Negative (ER/PR/HER2)
Eligibility: histologic dx by core or incisional bx; measurable dz >/= 1 cm; pt must agree to pretreatment research biopsies; no prior chemo, hormonal therapy or RT for this cancer;  performance status 0-1: Rx: Paclitaxel followed by ddAC +/- Bevacizumab vs Paclitaxel + Carboplatin followed by ddAC +/- Bevacizumab. (BEVACIZUMAB SUPPLIED).

4. SWOG 0800
HER2-negative Inflammatory or Locally Advanced
Eligibility: women with stage IIIb or stage IIIa/IIb unresectable dz; no prior chemo, biologic therapies or RT for breast cancer within 5 yrs; prior hormonal Rx okay but must D/C 7 days prior to protocol Rx; performance status 0-2: Rx: Bev + nab-paclitaxel x 12 wks --> AC + PEG-G q 2 wks x 6 versus Nab-paclitaxel q wk x 12 --> AC + PEG-G q 2 wks x 6 versus AC + PEG-G q 2 wks x 6 --> nabj-paclitaxel x 12 wks. (BEVACIZUMAB AND NAB-PACLITAXEL SUPPLIED)

BREAST PROTOCOLS: Stages 0-II

1.  NSABP B-39: (RTOG 0413)
Stages 0 - II Treated by Lumpectomy (Closed to the following low risk groups: women >/= 50 yrs with DCIS only or with node negative, hormone positive invasive cancer)
Eligibility: tumor < 3.0 cm; no more than 3 positive nodes; no bilateral dz; must enroll prior to start of adj chemo and within 42 days of last surgery for breast cancer: RX: Whole breast irradiation versus partial breast irradiation (approved for use at Doctors Medical Center and East Bay Radiation Oncology Center only).

2.  NSABP B-43
HER2-positive DCIS
Eligibility: tumors must be HER2 positive by centralized testing (pts must agree to centralized HER2 testing pre-entry); tumor completely removed by lumpectomy; axillary staging not required but if done must be node-negative; enroll </= 120 post-op; no multicentric disease: Rx: RT +/- Trastuzumab (TRASTUZUMAB SUPPLIED)

3. SWOG 0812
Premenopausal Women at High Risk for Breast Cancer
Eligibility: Premenopausal, age 18-50; DCIS/LCIS dx or mutation in BRCA1 / BRCA2 / PTEN / TP53 or Modified Gail/CARE model risk at 5 years > 1.67%; available breast for imaging (not previously irradiated); no known invasive breast cancer; no breast implants;  option for breast biopsy. RX: Cholecalciferol + vitamin D3 x 12 months versus identical Placebo + vitamin D3 x 12 months. (DRUGS PROVIDED)

BREAST PROTOCOLS: Stages I-III

1. CTSU MA.32
Post Surgery and/or Chemotherapy
Eligibility: invasive breast cancer completely resected within 12 months of enrollment; pT1c-3; pN0-3; M0 (refer to protocol section 5.1.4 for specific details); no clinical T4; Her2 +/- ok; completed surgery and/or chemo at least 4 wks prior to enrollment; bilateral breast CA ok if synchronous; performance status 0-2; age >18 <75 and at least 5 year life expectancy.
Rx: Metformin x 5 yrs versus identical Placebo x 5 yrs. (DRUG SUPPLIED)

2. NSABP B-47
Node Positive or High Risk Node Negative and HER2-low
Eligibility: Node pos. If node neg, must have one of the following: pT2 and ER/PgR neg; or pT2 and ER + (PgR +/-) and either grd 3 hist or Oncotype RS > 25; Must be HER2 low: IHC 1+ or 2+; FISH < 2.0. Enroll w/in 84 days of last surgery. Bilateral or inflammatory CA not eligible. Chemo choice: Docetaxel + Cyclophosphamide (TC) or Adriamyacin+Cyclophosphamide (AC) > wkly Taxol (T). RX: TC or AC > wkly T versus TC + Trastuzumab or AC > T + Trastuzumab (TRASTUZUMAB SUPPLIED)

3. SWOG 1007
Node-pos (1-3 nodes); ER/PgR Positive; HER2 Neg; RS < 25
Eligibility: Node pos (1-3 nodes); ER and/or PgR pos; HER2 Neg; If Oncotype DX RS known and < 25, eligible to register to step 2 (w/in 84 days after surgery); If no Oncotype DX test performed yet, must submit tissue for testing between 28 days and no later than 56 days after surgery; Performance status: 0-2; No prior treatment for this cancer; Metastatic or inflammatory not eligible; Men not eligible. RX: Oncotype DX Recurrence Score < 25 then Randomize: Chemo + Endocrine therapy versus Endocrine therapy (no chemo).  

4. SWOG 0221
Node Positive and High-risk Node Negative (see protocol for risk criteria)
Eligibility: Stage I-III, synchronous bilat dz OK(w/in 1 month); T4 tumors not OK; HER2-positive tumors OK; men OK; no CHF or active angina; enroll w/in 84 days of surgery: RX: AC + PEG-G x 4 followed by q 2 wk T + PEG-G x 6 versus AC + PEG-G x 4 followed by weekly T x 12 versus AC + G x15 followed by q 2 wk T + PEG-G x 6 versus AC + G x15 followed by weekly T x 12. (G-CSF SUPPLIED- contact Amgen for financial assistance with PEG-G if needed)

BREAST PROTOCOLS: Locally Advanced/Recurrent/Metastatic

1. CTSU E2108
Intact Primary Tumor with Metastatic Breast Cancer
Eligibility: Intact primary Br CA (not recurrent); CNS mets eligible (as long survival > 6 mos); at least one site of metastatic disease; Males eligible; prior non-invasive DCIS eligible. RX: (step 1) Optimal systemic therapy. If CR, PR or SD à (step 2 randomize): continued systemic therapy versus surgery + RT (primary tumor) > systemic therapy. (NO DRUGS SUPPLIED)

2. CTSU N0733
HER2-positive and Previously Treated with Trastuzumab
Eligibility:locally adv (T4 & stg IIIb or IIIc) or metastatic dz; only 1 prior chemo regimen containing Trastuzumab with an anthracycline and/or a taxane in the adj or adv/met setting; unlimited prior hormonal Rx okay; measurable dz by RECIST; performance status 0 - 2; men okay: Rx: Capecitabine and Lapatinib +/- IMC-A12. (IMC-A12 and LAPATINIB SUPPLIED)

3. SWOG 0800
HER2-negative Inflammatory or Locally Advanced
Eligibility: women with stage IIIb or stage IIIa/IIb unresectable dz; no prior chemo, biologic therapies or RT for breast cancer within 5 yrs; prior hormonal Rx okay but must D/C 7 days prior to protocol Rx; performance status 0-2: Rx: Bev + nab-paclitaxel x 12 wks --> AC + PEG-G q 2 wks x 6 versus Nab-paclitaxel q wk x 12 --> AC + PEG-G q 2 wks x 6 versus AC + PEG-G q 2 wks x 6 --> nabj-paclitaxel x 12 wks. (BEVACIZUMAB AND NAB-PACLITAXEL SUPPLIED)

BREAST PROTOCOLS: Surgical

1.  ACOSOG Z1071 (temporarily closed to accrual)
Node Positive Breast Cancer (T1-4, N1-2, M0)
Eligibility: positive FNA or core bx of axillary node (prior to neoadj Rx); planned or completed neoadj chemo; no prior ipsilateral axillary surgery or/excisional biopsy or treatment of hidradenitis; performance status 0-1: Surgery:  SLN and ALND

CANCER CONTROL/SYMPTOM MANAGEMENT PROTOCOLS

1.  CALGB 70305 (limited available space)
Prevention of Lymphedema
Eligibility- step 1: Newly diagnosed clinical stage I-III breast cancer; no hx LCIS, DCIS or invasive breast cancer; planned neoadj Rx is okay; arm circumference </= 17 inches measured pre-op and, if applicable, pre neoadj RX: step 2: full axillary node dissection including 10 or more nodes. Intervention: LEAP (lymphedema education with a comprehensive exercise program).

2.  CALGB 70604
Zoledronic Acid for Bone Metastases
Eligibility:  adenocarcinoma of breast or prostate; multiple myeloma; at least 1 bone met by radiographic imaging; no brain mets; no prior IV bisphosphonate; no prior radiopharmaceuticals; no current investigational agents; performance status 0-2: RX: Zoledronic acid q 4 weeks versus q 12 weeks. (NO DRUG SUPPLIED) Companion study: SWOG S0702

3. CALGB 70806
Vitamin D and Breast Cancer Biomarkers
Eligibility: premenopausal women </= 55 yrs; regular menstrual cycles; breast density >/= 25% (BIRAD-2 scattered fibroglandular densities or greater); no prior breast or ovarian cancer or DCIS; no HRT, tamoxifen or raloxifene; breast implants or breast reduction not eligible; no vitamin D above 400 IU/day: Rx: Vitamin D 2000 IU/day x 12 months versus placebo (VITAMIN D/PLACEBO PROVIDED)

4. NSABP DMP-1:
Evaluate Decision Making for Women at Increased Risk for Breast Cancer
Eligibility: Identified by physician to be at increased risk for breast cancer and will discuss use of SERMs for risk reduction; Female; Age > 35; English speaking; No prior breast cancer, DCIS or LCIS; No participation in other cancer or osteoporosis prevention studies; No hx of tamoxifen, raloxifene or other SERM therapy. Evaluations: Counseling Session for potential SERM use: (study enrollment) followed by Questionnaire 1 completion; At 3 months or 6 months: Questionniare 2 completion.

5. NSABP P-5
Polyp prevention in Pts with Resected Colon Cancer
Eligibility: completely resected stg I or II adenoca of the colon; must enroll within 1 year of surgery; performance status 0 or 1; hyperlipidemia with indication for statin therapy not allowed; no familial adenomatous polyposis, malabsorption syndrome, ulcerative colitis or inflammatory bowel disease:  Rx: Rosuvastatin 10 mg po qd x 5 yrs VS placebo
(DRUG SUPPLIED)

6. SCUSF 0806
Reduction of Cardiotoxicity in Pts Receiving (Neo)Adjuvant Herceptin
Eligibility: female pts diagnosed with HER2-pos breast cancer; scheduled to received (neo)adjuvant Herceptin; LVEF >/= 50%; no prior Herceptin or anthracycline; no ACE inhibitors, beta blockers or digoxin: Rx: Lisinopril 10 mg VS Coreg CR 10 mg VS placebo (DRUGS PROVIDED)

7. SWOG 0702
ONJ Associated with Zoledronic Acid Treatment
Eligibility: bone metastases from multiple myeloma or solid tumor for which IV bisphosphonate treatment is indicated; plans to receive Zoledronic acid w/in 30 days; prior oral bisphosphonate OK; prior IV bisphos for bone mets allowed w/in 90 days of rando; 3 prior doses of IV bisphos w/in 3 yrs allowed for low bone mass; no prior RT to maxillofacial area; no preexisting ONJ; performance status 0-3: Intervention: dental evaluation q 6 mos. (NO DRUG SUPPLIED) Companion study: CALGB 70604

8. SWOG S0927
Control AI-induced pain/stiffness in early stage Breast CA
Eligibility: Postmenopausal women dx invasive breast cancer stage I-III; ER/PR positive; Taking AI: Arimidex, Femara or Aromasin for at least past 90 days; qualified degree (at least 5) of worst pain/stiffness since beginning AI therapy; Performance status 0-2; ability to complete questionnaires in English; not taking anticoagulation, narcotic, topical analgesic medication; blood/urine specimen collection required. RX: Omega-3-Fatty Acid x 24 wks versus identical Placebo x 24 wks. (DRUG SUPPLIED).

GI PROTOCOLS: Colo-Rectal

1. CALGB 80405
Locally Advanced (unresectable) or Metastatic Disease
Eligibility: Must have wild type K-ras gene as determined by central lab. No prior treatment for advanced dz; no prior Bevacizumab or Cetuximab; no history of significant bleeding ; no pleural effusion or grade 2 dyspnea; no CNS metastases; no periperal neuropathy =/> grade 2: RX: FOLFOX or FOLFIRI (physician's choice) + Bevacizumab versus FOLFOX or FORFIRI + Cetuximab versus FOLFOX or FOLFIRI + Bevacizumab and Cetuximab. (CETUXIMAB SUPPLIED)

2. CALGB 80702
Stage III Completely Resected Adenocarcinoma of the Colon
Eligibility: en bloc resection for tumors adherent to adjacent structures; at least 1 pos node; no evidence of residual nodal dz; rectal cancer not eligible; synchronous tumors okay; NSAIDs not allowed nor aspirin exceeding 325 mg 3 x per week on average; must begin Rx 21 – 56 days post-op: Rx: FOLFOX  x 12 cycles + Celecoxib/placebo versus FOLFOX x 6 cycles + Celecoxib/placebo  (CELECOXIB/PLACEBO SUPPLIED)

3. NSABP P-5
Polyp prevention in Pts with Resected Colon Cancer
Eligibility: completely resected stg I or II adenoca of the colon; must enroll within 1 year of surgery; performance status 0 or 1; hyperlipidemia with indication for statin therapy not allowed; no familial adenomatous polyposis, malabsorption syndrome, ulcerative colitis or inflammatory bowel disease:  Rx: Rosuvastatin 10 mg po qd x 5 yrs VS placebo. (DRUG SUPPLIED)

GU PROTOCOLS: Bladder/Urinary Tract

1. CALGB 90601
Progressive, Metastatic or Locally Advanced Transitional Cell ca of the Urinary Tract
Eligibility: T4b, N2, N3 or M1 disease of bladder, ureter, renal pelvis, prostate or urethra; prior (neo)adj chemo okay if >/= 1 year to progression; no prior systemic combination chemo for metastatic dz; no prior angiogenesis inhibitors; no known brain mets; no CHF: Rx: Gencitabine/Cisplatin x 6 cycles (max) + Bevacizumab/placebo until dz progression. (BEVACIZUMAB/PLACEBO SUPPLIED)

GU PROTOCOLS: Renal

1. CALGB 90802
Previously Treated Advanced Renal Cell Carcinoma
Eligibility: stage IV renal cell cancer with clear cell component; progressive dz after Rx with at least 1 VEGFR TKI therapy; no prior VEGF binding agent or mTOR inhibitor; no active brain mets; performance status 0-2: RX: Everolimus 10mg po qd plus Bevacizumab or placebo 10 mg/kg IV q 2 wks.

2. SWOG 0931
Intermediate or Very High Risk Renal Cell Carcinoma
Eligibility: Clear cell or non-clear cell allowed (collecting duct or medullary carcinomas excluded); requires full surgical resection (radical or partial nephrectomy incl. removal of all clinically pos lymph nodes); negative margins; bilateral renal tumors eligible; no residual or distant mets; no prior anti-cancer therapy (except surgery); Performance status: 0,1. RX: Everolimus 10 mg daily x 54 weeks versus Placebo (EVEROLIMUS/PLACEBO PROVIDED)

GYN PROTOCOLS: Ovary

1. GOG 0262
Stage III suboptimally debulked or Stage IV
Eligibility: Stage II, III or Stage IV; no “borderline” tumors of low malignant potential; no prior chemo for an abdominal or pelvic tumor; no prior targeted therapy or hormonal therapy for this cancer; no prior abdominal or pelvic RT; must enroll within 12 wks of staging surgery; performance status 0-2; Rx: Carbo/Taxol day 1 q 21 days +/- Bev versus Carbo day 1 + Taxol days 1, 8 & 15 q 21 days +/- Bev   Pts will choose optional Bevacizumab.  (BEVACUZUMAB PROVIDED)

HEAD & NECK PROTOCOLS

1.  CTSU E1305
Recurrent or Metastatic Disease
Eligibility: SCC of H&N, any primary; recurrent and incurable by surgery or metastatic; no prior chemo or bio therapy for rec/met dz; 1 prior regimen of induction or adj chem and/or RT with curative intent allowed; must be > 6 months since last chemo and/or RT; palliative RT to H&N allowed but must be > 8 wks since last dose; no prior Bev; no brain mets; Rx: physician choice of Docetaxel/Cisplatin or Cisplatin/5FU; pt then randomized to chemo +/- bevacizumab. (BEVACIZUMAB SUPPLIED)

LUNG PROTOCOLS: Non-small Cell

1. CALGB 30607
Stage IIIB/IV; Maintenance Therapy
Eligibility:  pts must have received 4 cycles platinum based doublet therapy +/- bevacizumab; no evidence of progression; no prior adj chemo for stg I-III resected dz or combined modality Rx for stage III NSCLC; Rx:  Sunitinib, 37.5 mg po daily versus Placebo.  (SUNITINIB/PLACEBO SUPPLIED)

2.  CTSU E1505
Completely Resected NSCLC
Eligibility: Stage IB – IIIA (If IB, tumor >/= 4 cm); wedge resection or segmentectomy NOT allowed; mediastinal lymph node sampling expected; no prior chemo; performance status 0-1; 6-12 weeks post-op: RX: One of 3 chemo regimens +/- Bevacizumab (Investigator may choose Cisplat/Vinorelbine or Cisplat/docetaxel or Cisplat/gemcitabine). (BEVACIZUMAB SUPPLIED)

3.  SWOG 0819
Stage IV Newly Diagnosed or Recurrent
Eligibility:  measurable or non-measurable dz; performance status 0-1; no prior chemo, cetuximab, gefitinib, erlotinib or agents that target EGFR pathway; no VEGF related agents; no chimerized or muring monoclonal antibody therapy; nodules in an ipsilateral non-primary lobe with no other M1 dz will not be considered stage IV: Rx: Chemo +/- Bevacizumab versus Chemo with Cetuximab +/- Bevacizumab (CETUXIMAB SUPPLIED)

4. SWOG S0709
Stage IIIB, IV or Recurrent NSCLC selected by Proteomic testing; PS = 2
Eligibility: newly dx Stage IIIB or IV or recurrent dz after surgery and/or irradiation; must submit blood sample for proteomic testing and have “VeriStrat positive” result to qualify for further study participation; Performance status must be 2; if prior RT, 14 days must elapse and recovery from side effects by registration; if prior adjuvant chemo, 1 yr must have elapsed since completion; no prior hormone, chemo or biologic tx for advanced NSCLC; measurable or non-measurable disease. RX: OSI-774 daily continuously versus OSI-774 + Carboplatin + Paclitaxel x 4 cycles, followed by OSI-774 daily continuously. (OSI-774 SUPPLIED)

LUNG PROTOCOLS: Small Cell

1. CALGB 30504 (Permanent accrual closure effective: 12/13/11)
Untreated Extensive Stage Disease
Eligibility: must have measurable disease; no prior chemo for SCLC; prior RT okay; performance status 0 - 2; no brain mets; Rx: Cisplatin or Carbo + Etoposide q  21 days for up to 6 cycles. After a min of 4 cycles patients with responding or stable dz are randomized to sunitinib/placebo.  Those on placebo crossover to Sunitinib at progression.
(SUNITINIB/PLACEBO & SUNITINIB OPEN LABEL SUPPLIED)

2. CALGB 30610
Limited Stage
Eligibility: No prior resection; no prior chemo or RT for SCLC; no prior thoracic RT; measurable or non-measurable dz; performance status 0-2; RX: Cisplatin/Etoposide X 4 cycles plus one of three radiotherapy regimens (3 arm study).  (NO DRUG SUPPLIED)