BREAST PROTOCOLS: Neoadjuvant

1.  ACOSOG Z1031
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  for 16 -18 weeks followed by surgery.  Continue post – op Anastrozole or Tamoxifen X 5 years.  Post-op chemo and/or RT at physician’s discretion. (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.

3. NSABP B-40
Neoadjuvant Chemotherapy
Eligibility: dx by core needle biopsy; tumor palpable and >/= 2.0 cm; tumor cannot be strongly HER2 positive; performance status 0 - 1; LVEF >/= LLN: RX: 6 arm study: Docetaxel  Q 3swks X 4  versus Docetaxel/Capecitabine Q 3 wks X 4 versus Docetaxel/Gemcitabine Q 3 wks X 4 ( each arm +/- Bevacizumab) and each  followed by AC Q 3wks X 4 (+/- Bevacizumab). (CAPECITABINE, GEMCITABINE & BEVACIZUMAB 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.  PACCT-1 (TAILORx)
Stage I-II, ER and/or PR Positive, Node-negative
Eligibility: Tumor size 1.1 - 5.0 cm or:  5 mm - 1 cm with unfavorable histologic features; HER2 neg by FISH or IHC; pt agreeable to standard adj chemo and hormonal therapy; pre-register within 84 days post-op; submit tissue for determination of recurrence score (RS) within 3 days of pre-registration (uninsured pts will not be billed for Oncotype Dx assay)" : RX:  RS < 11 will be assigned hormonal Rx only; RS > 25 will be assigned Chemo + hormonal Rx; RS 11-25 will be randomized to hormonal Rx only versus Chemo + hormonal Rx. (NO DRUG SUPPLIED)

BREAST PROTOCOLS: Stages I-III

1.  CALGB 40101
High-risk, 0-3 Positive Nodes
Eligibility: If node-negative, tumor must be  > 1 cm or ER or PR negative; < 84 days since last breast surgery; sentinel node dissection is adequate if negative; no prior anthracycline; no prior chemo for this cancer; no more than 4 wks of Tam for this cancer; no inflammatory ca; no prior Evista/Raloxifene; bilat dz OK: RX: AC (4 versus 6 cycles) or Taxol (4 versus 6 cycles). (NO DRUG SUPPLIED)

2.  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)

3.  CTSU N063D (ALTTO) (Design 1 is closed)
Adequately Resected, HER-2 Positive 
Eligibility: Node positive or node negative if tumor >/= 1.0 cm; performance status </= 1; must have completed at least 4 cycles of anthracycline-based chemo (adj or neoadj); no prior anti HER-2 therapy; If docetaxel is indicated, must be given prior to enrollment (Design 1); If a taxane is indicated rando prior to start (Design 2); RT may be given concurrent with protocol therapy; men OK: RX: Herceptin versus Lapatinib versus Herceptin followed by Lapatinib versus Herceptin plus concurrent Lapatinib. (LAPATINIB SUPPLIED)

4.  IBCSG 24-02 (SOFT)
Premenopausal Women with ER and/or PR Positive Tumors
Eligibility: completely resected breast cancer; bilat dz OK; pts not receiving chemo must enroll within 12 wks of surgery; pts receiving chemo must enroll within 8 months after last dose of chemo; hormonal therapy allowed up to 8 months after diagnosis: RX: Tamoxifen vs Tamoxifen + ovarian function suppression vs Exemestane + ovarian function suppression. (TRIPTORELIN & EXEMESTANE SUPPLIED)

5. 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)

6. SWOG 0307
Bisphosphonates for Stage I -III
Eligibility: Resected primary tumor; (pos margins OK); multifocal dz OK; pts must receive adjuvant Rx (chemo, hormonal or combo); can be registered prior to, during or up to 8 weeks after chemo; if hormonal Rx only register within 12 weeks of surgery; RX: Zoledronic Acid vs Clodronate vs Ibandronate. Must start w/in 5 days of rando.  Can do w/C40101, E5103, SOFT (if on S0307 first), but not B-39. (ALL 3 DRUGS SUPPLIED)

BREAST PROTOCOLS: Locally Advanced/Recurrent/Metastatic

1. CALGB 40302
Postmenopausal Women with ER and/or PR Positive Tumors
Eligibility: At least 1 and up to 2 prior hormone therapies; Tumor expression of HER2 (IHC 1+, 2+ , 3+ levels OR FISH positive OR serum HER@ ECD >/= 15 ng/ml); measurable dz required except for pts with bone mets only; no symptomatic CNS mets: RX: Fulvestrant + Placebo vs Fulvestrant + Lapatanib. (LAPATINIB/PLACEBO SUPPLIED; FULVESTRANT SUPPLIED FOR CYCLE 1 ONLY)

2. 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.

3. 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)

4.  CTSU E1105
Metastatic DZ and/or Chest Wall Recurrence; HER-2 Overexpressing
Eligibility: HER-2 gene amplification by FISH or 3+ result by IHC using Herceptest (DAKO); prior hormone therapy and/or RT for met dz allowed; no prior chemo, herceptin or Bevacizumab for met dz; adj herceptin and/or taxane allowed if > 12 months; men OK: RX:  Chemo with Taxol +/- Carbo (investigators choice) + Herceptin + Bevacizumab or placebo. (BEVACIZUMAB/PLACEBO SUPPLIED)

5.  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)

BREAST PROTOCOLS: Miscellaneous

1. NSABP B-42
Post Menopausal Patients Completing 5 Years of Adjuvant Hormonal Therapy
Eligibility: ER and/or PR positive primary invasive breast cancer stage I, II or IIIA; completed 5yrs of treatment with an AI or up to 3 yrs of tamoxifen followed by an AI for a total of 5 yrs; performance status 0-1: RX: Letrozole/placebo once daily for 5 years. (LETROZOLE/PLACEBO SUPPLIED)

CANCER CONTROL/SYMPTOM MANAGEMENT PROTOCOLS

1.  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).

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)

3. HLMCC 0501
Stress Management for Chemotherapy Patients (Closed to non-Hispanic patients)
Eligibility: new diagnosis of cancer; scheduled to receive at least 4 cycles of chemo; no concurrent RT; no severe depression: RX: Usual care only versus Stress Mgmt Training kit + usual care. (STRESS MGMT KIT SUPPLIED)

4. 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)

5. SWOG 0715 (to open soon)
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 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.  CTSU E5202 (Accrual suspended 04/30/09)
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)

3. CTSU N0147 (Closed to pts > 70 years)
Stage III Colon Cancer
Eligibility: tumor resected en bloc within 56 days of enrollment; at least 1 pos lymph node; no evidence of residual nodal disease; performance status 0 - 2; no significant peripheral neuropathy; must submit tissue block for K-ras testing w/in 42 days of surgery; pts with wild type K-ras will be randomized; pts with mutant K-ras will be followed on Arm G with Rx at discretion of physician: RX: Randomization to FOLFOX versus FOLFOX + Cetuximab. (OXALIPLATIN & CETUXIMAB SUPPLIED)

4. NSABP R-04
Rectal Cancer: Neoadjuvant
Biopsy confirmed adenocarcinoma.  Clinical stage II or III.  Eligibility:  Measurable disease. Zubrod 0-2. No prior RT or chemo. Arm 1: Pre-op RT + 5-FU followed by Surgery. Arm 2: Pre-op RT + 5-FU/Oxaliplatin followed by surgery; Arm 3: Pre-op RT + Capecitabine followed by surgery; Arm 4: Pre-op RT + Capeticabine/Oxaliplatin followed by surgery. (CAPECITABINE & OXALIPLATIN SUPPLIED)

5.  SWOG 0600 (Temporarily Closed)
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)

GI PROTOCOLS: Stomach

1. CALGB 80101
Surgically Resected Adenocarcinoma of Stomach or GE Junction
Eligibility: Stages II, IIIA, IIIB or IV if MO. M1 not allowed. No prior chemo or RT. Zubrod 0-2. Documentation of stable weight for 1 week prior to enrollment. RX: 5FU/LV followed by 5FU + RT followed by 5FU/LV versus ECF followed by 5FU +RT followed by ECF. (NO DRUG SUPPLIED)

GU PROTOCOLS: Prostate

1. SWOG 0421
Advanced Hormone Refractory
Eligibility: adenocarcinoma of prostate, any T, any N, M1b; must have evidence of bone mets on bone scan; refractory to hormone Rx; no prior chemo for met dz; prior RT and/or surgery allowed; bisphosphonates permitted; RX: Docetaxel/Prednisone + Atrasentan/Placebo X 12 cycles followed by Atrasentan/Placebo for a total of 52 weeks. (ATRASENTAN/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)

2.  CTSU E 2805
Unfavorable Renal Cell Carcinoma
Eligibility: T1b-T4, N0-2, M0 ; no prior treatment other than surgery; no clinically significant cardiovascular dz or uncontrolled HTN; baseline LVEF above LLN; randomize 3-10 weeks post-op: RX: Sunitinib + placebo versus Sorafenib + placebo versus placebo + placebo. (SUNITINIB/PLACEBO & SORAFENIB/PLACEBO SUPPLIED)

GYN PROTOCOLS

1.  CTSU GOG 0218
Stage III or IV Epithelial Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Eligibility: surgery for histologic diagnosis, staging and maximal effort at debulking is required; pt must enroll within 12 wks of surgery; no prior Rx for this dz; no prior RT to pelvis; no prior chemo for any abd or pelvic tumor; performance status 0 -2; Rx: Carbo/Taxol + concurrent bevacizumab followed by extended bevacizumab versus Carbo/Taxol + concurrent bevacizumab followed by extended placebo versus Carbo/Taxol + concurrent placebo followed by extended placebo. (BEVACIZUMAB/PLACEBO SUPPLIED)

2. CTSU GOG 0219
Carcinoma of the Cervix (SCC, adeno or adenosquamous)
Eligibility: Stages IB2, IIA (> 4 cm), IIB, IIIB and IVA; para-aortic nodes negative or non-suspicious; no prior treatment; no prior/planned hysterectomy for this cancer; no lower one-third vaginal involvement; no uncontrolled HTN; performance status 0-3: RX: concurrent Cisplatin/RT versus concurrent Cisplatin/Tirapazamine/RT. (TIRAPAZAMINE SUPPLIED)

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 (Accrual temporarily suspended 03/10/09)
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 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)

3.  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)

LUNG PROTOCOLS: Small Cell

1. 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

1. SWOG 0438 (Temporarily closed 02/15/09)
Unresectable Stage IV Disease of Cutaneous or Mucosal Origin
Eligibility: measurable dz; performance status 0 - 1; no history of brain mets; no systemic Rx for stg IV dz; prior adj Rx allowed if > 90 days from registration; no prior BAY 43-9006, VEGF/VEFGR, CCI-779 or R115777 or other agents targeting MAPkinase pathway or farnesyl transferase: RX: BAY 43-9006 PO BID plus CCI-779 IV weekly versus BAY 43-9006 PO BID plus R115777 PO QD. (ALL 3 DRUGS SUPPLIED)