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)