BREAST PROTOCOLS: Neoadjuvant

1.  ACOSOG Z1031 - Accrual suspended pending IRB review of Amend #7
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 versus Taxol weekly + Lapatinib po qd x 16 weeks. (LAPATINIB SUPPLIED)

3. CALGB 40603
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 à ddAC +/- Bevacizumab vs Paclitaxel + Carboplatin à ddAC +/- Bevacizumab (BEVACIZUMAB/PLACEBO 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)

BREAST PROTOCOLS: Stages I-III

1.  CTSU E5103
Node Positive and High-risk Node Negative 
Eligibility: node pos or node neg with one of the following- ER neg tumor >/= 1 cm; or ER pos tumor >/= 5 cm; or ER pos tumor between 1 & 5 cm with recurrence score >/= 11; must be </= 84 days post-op; HER+ not eligible; men OK: RX: AC + placebo > T + placebo versus AC + Bev > T + Bev versus AC + Bev > T + Bev > Bev. (BEV/PLACEBO SUPPLIED)

2. CTSU MA.32
Post Surgery and/or Chemotherapy
Eligibility: invasive breast cancer completely resected within 12 months of enrollment; pT1-3; pN0-3; M0 (see protocol section 5.1.4 for further details); completed surgery and/or chemo at least 4 wks prior to enrollment; performance status 0-2; age < 75 and 5 yr life expectancy: Rx: Metformin 850 mg po bid x 5 years versus identical placebo (DRUG SUPPLIED)

3.  CTSU N063D (Design 2B only)
HER-2 Positive 
Eligibility: Node positive or node negative if tumor >/= 1.0 cm; sentinel node dissection is adequate if negative; performance status </= 1; must enroll within 8 wks of definitive surgery; no bilateral breast cancer; men okay: Rx: Docetaxel/Carbo (6 cycles) + Herceptin (52 wks) VS Docetaxel/Carbo (6 cycles) + Lapatinib (52 wks) VS Docetaxel/Carbo (6 cycles) + concurrent Herceptin (18 wks) followed by Lapatinib (28 wks) VS Docetaxel/Carbo (6 cycles) + Herceptin & Lapatinib (52 wks) (LAPATINIB SUPPLIED)

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 6 followed by q 2 wk T + PEG-G x 6 versus AC + PEG-G x 6 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. CALGB 40502
Stage IV or IIIB not Amenable to Local Therapy
Eligibility: measurable disease; no prior chemo for stg IV or IIIB disease; prior neoadj, adj Rx allowed; prior bevacizumab allowed; HER2 pos pts must have rec'd Herceptin or Lapatinib; ECOG performance status 0-1; men OK: Rx: Paclitaxel + bevacizumab vs Nab-paclitaxel + bevacizumab vs Ixabepilone + bevacizumab. (NAB-PACLITAXEL, BEVACIZUMAB AND IXABEPILONE SUPPLIED)

2. CALGB 40503
Unresectable Stage IIIB or Stage IV
Eligibility: ER and/or PR positive; measurable or non-measurable dz; no prior chemo for met dz; no hormonal Rx for met dz unless initiated within 4 wks of registration; prior adj/neoadj chemo and/or hormonal Rx allowed; performance status </= 1: RX: Endocrine therapy (Tam or Letrozole) plus Bevacizumab or Placebo q 21 days (ovarian suppression is required for premenopausal pts). (BEVACIZUMAB/PLACEBO & LETROZOLE SUPPLIED)

3. 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)

4.  SWOG 0622
Stage IV, Bone Metastasis Predominant DZ
Eligibility: the number of bone mets must be = or > than the number of non-bone, measurable lesions; if nonmeasurable dz only, pt must have rising CA 15-3 or CA 27-29; 1 prior chemo for met dz allowed; if ER/PR+, must have had at least 1 hormonal Rx for met dz; men OK: RX: Dasatinib, 100 mg PO QD versus Dasatinib, 70 mg PO BID. (DASATINIB SUPPLIED)

5. 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
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 170601
Treatment of Chemo Induced Peripheral Neuropathy (PN)
Eligibility: >/= grade 2 peripheral sensory neuropathy (interfering with function); past Rx with taxol or oxaliplatin (not both); >/= 3 months since completion of Rx; no pre-existing PN; no use of vitamin supplements above recommended daily allowances; no antidepressants or anticonvulsants; no warfarin or heparin; stable doses of analgesics for PN okay: Rx: duloxetine/placebo (DULOXETINE/PLACEBO SUPPLIED)

2.  CALGB 70305
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).

3.  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)

4. HLMCC 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)

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. 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)

7. SWOG 0715
Prevention of Taxane Induced Neuropathy
Eligibility: women with resected stg I-IIIa breast cancer; plans to receive one of 5 std taxane regimens; concurrent biologic therapy OK; other therapeutic trials OK; performance status 0-2: RX: Acetyl-L Carnitine (ALC) or Placebo po daily x 24 wks (ALC/PLACEBO 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; 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.  CTSU E5202
Stage II Colon Cancer; High Risk versus Low Risk for Recurrence (must submit tumor block to ECOG to determine risk for recurrence)
Eligibility: T3 or T4, N0, M0; at least 8 nodes evaluated; perforation or complete obstruction not allowed; no history of bleeding, TIA, thromboembolic events, peripheral vascular dz or NYHA Class III/IV cardiac dz; no active GI ulcer  RX: low risk pts are registered to observation only; high risk pts are randomized to FOLFOX +/- Bevacizumab. (BEVACIZUMAB & OXALIPLATIN SUPPLIED)

4. 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)

5.  SWOG 0600
Stage IV Colorectal Cancer; 2nd Line Therapy
Eligibility: pts must have progressed on 1st line Rx with bevacizumab + FOLFOX, OPTIMOX or XELOX; progression must be within 90 days of last dose of bevacizumab; measurable or non-measurable dz;  no prior irinotecan, cetuximab or other VEGF/EGFR targeting agents; prior RT and/or surgery allowed:  RX: FOLFIRI or irinotecan + cetuximab versus FOLFIRI or irinotecan + cetuximab + lower dose bevacizumab versus FOLFIRI or irinotecan + cetuximab + higher dose bevacizumab. (BEVACIZUMAB & CETUXIMAB 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.  CTSU E2804
Advanced Renal Cell; Clear Cell Variant with < 25% Other Histologies
Eligibility: measurable metastatic disease not curable by std RT or surgery; no CNS disease; 1 prior immunotherapy regimen for advanced dz allowed; no prior anti-angiogenic therapy; prior RT allowed; Rx: Bevacizumab versus Bevacizumab + Temsirolimus versus Bevacizumab + Sorafenib versus Temsirolimus + Sorafenib. (ALL 3 DRUGS SUPPLIED)

GYN PROTOCOLS: Ovary

1. SWOG 0904
Recurrent, Refractory, Progressive/Persistent Disease
Eligibility: epithelial ovarian, fallopian tube or primary peritoneal cancer; measurable or non-measurable dz; 1 prior platinum-based regimen for primary dz required; no anti-VEGF therapy or vandetanib; chemo for advanced dz okay but no docetaxel or non-cytotoxic therapy (except hormone therapy): Rx: Docetaxel + concurrent Vandetanib VS Docetaxel followed by Vandetanib at time of dz progression.

HEAD & NECK PROTOCOLS

1.  CTSU E1305
Recurrent or Netastatic 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 30605
Poor Risk Stage III NSCLC
Eligibility: Unresectable Stage IIIA or IIIB; measurable dz; no prior chemo or RT for NSCLC; performance status = 2 OR performance status 0-1 and >/= 10% wt loss: RX: Abraxane + Carbo X 2 cycles followed by RT + concurrent Erlotinib 150 mg PO QD. (ERLOTINIB & ABRAXANE SUPPLIED)

2. 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)

3.  CALGB 30704
Second Line Treatment of Advanced NSCLC
Eligibility: stage IIIB or IV with evidence of progression during/following 1st line Rx; only one prior regimen for advance dz; no prior VEGFR inhibitors; no prior pemetrexed; measurable or non-measurable dz; performance status 0 -1; Rx: Pemetrexed versus Sunitinib versus Pemetrexed + Sunitinib. (SUNITINIB SUPPLIED)

4.  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)

5.  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)

LUNG PROTOCOLS: Small Cell

1. CALGB 30504
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)

MELANOMA PROTOCOLS

2. SWOG 0826
Stage IV Disease of Cutaneous or Mucosal Origin
Eligibility: measurable or non-measurable dz; unknown primary okay; performance status 0-1; up to 1 prior systemic Rx for stage IV dz; any number of adj system therapies allowed; prior RT and prior surgery allowed: Rx: SCH 727965 iv q 21 days (SCH 727965 SUPPLIED)