1. No category

CANCER RESEARCH
OPEN PROTOCOLS
November/December 2014
BREAST
DCIS
 CALGB 40903 Phase II Study of Neoadjuvant
Letrozole for Post menopausal Women with Estrogen
Receptor Positive Ductal Carcinoma in Situ (DCIS)
CC (1.3) CALGB 40903
Letrozole + MRI Surg
Adjuvant:
 SWOG S1007-A Phase III Randomized Clinical Trial
of Standard Adjuvant Endocrine Therapy +/Chemotherapy in Patients with 1-3 Positive Nodes,
Hormone Receptor-Positive and HER2-Negative
Breast Cancer with Recurrence Score (RS) of 25 or
Less.
Rx (1.6) SWOG S1007
1)Chemo+ endocrine Rx
(Additional $)
2) Endocrine Rx
 NSABP B-47 A Randomized Phase III Trial of
Adjuvant Therapy comparing Chemotherapy Alone (6
cycles of Docetaxel + Cyclophosphamide or 4 cycles
of Doxorubicin+Cyclophosphamide followed by
weekly Paclitaxel) to Chemotherapy+Trastuzumab in
Women with Node-Positive or High-Risk NodeNegative HER2- Low Invasive Breast Cancer.
Rx (1.6) NSABP B-47 1A) Taxo + ctx
2A) Taxo+ctx+Hercep→Hercep
1B) AC→paclit
2B) AC→paclit+Hercep→Hercep
NSABP B-55 – A Randomized, Double-Blind, Parallel
Group, Placebo-Controlled Multi-Center Phase III
Study to Assess the Efficacy and Safety of Olaparib
vs Placebo as Adjuvant Treatment in Patients with
Germline BRCA 1/2 Mutations and High Risk HER2
Negative Primary Breast Cancer Who have Completed
Definitive Local Treatment and Neoadjuvant or
Adjuvant Chemotherapy. (Triple Negative)
RX (1.0)
BRCA Screening →if positive →
1) Olaparib/Placebo
CC (1.0)
QOL
 SWOG S1207-Phase III Randomized, PlaceboControlled Clinical Trial evaluating the use of adjuvant
Endocrine Therapy +/-One Year of Everolimus in
Patient with High-Risk, Hormone Receptor + and Her 2
Negative Breast Cancer
Rx (1.6) SWOG S1207
Everlimus/placebo 1 year
5525-05 (11/12/2014)
Advanced
ADVANCED/METASTATIC
 ECOG E2108-A Randomized Phase III Trial of the
Value of Early Local Therapy for the intact Primary
Tumor in Patients with Metastatic Breast Cancer.
Rx (1.6) CTSU E 2108
Step 1: Opt chemo /MD
(ECOG)
Eval: → CR/PR/SD→Step2
1) Cont chemo
2) Surg +/- RT
CC (0.4) CTSU E2108
QoL
ECOG 7208 – A Randomized Phase II Study of
Irinotecan and Cetuximab with or without AntiAngiogenic Antibody, Ramucirumab (IMC-1121B), in
Advanced, K-Ras Wild-type Colorectal Cancer
Following Progression on Bevacizumab-Containing
Chemotherapy.
RX (1.6)
A) Irinotecan + Cetux
Additional $
C) Irinotecan + Cetux + Ramucirumab
SWOG S1222 – Fulvestrant Alone Versus
Fulvestrant and Everolimus Versus Fulvestrant,
Everolimus, and Anastrozole: A Phase III Randomized
Placebo-Controlled Trial in Postmenopausal with
Hormone-Receptor Positive HER 2 neg. Stage IV
Breast Cancer.
RX ($ )
Arm 1) Fulvestrant + Placebo (Everol)
+ Placebo (Anastrozole)
Arm 2) Fulvestrant + Everolimus +
Placebo (Anastrozole)
Arm 3) Fulvestrant + Everolimus +
Anastrozole
ADVANCED GASTRIC/ GE JUNCTION
GYN MALIGNANCIES
Ovarian/Fallopian Tube/Primary Peritoneal
NRG/GOG – A Phase II Evaluation of Elesclomol
Sodium and Weekly Paclitaxel in the Treatment of
Recurrent or Persistent Platinum-Resistant Ovarian,
Fallopian Tube or Primary Peritoneal Cancer
(RX 1.0)
Paclit + Elesclomol sodium
HEAD and NECK
ECOG/ACRIN E2112 – A randomized Phase III Trial
of Endocrine Therapy plus Entinostat/Placebo in
Postmenopausal Patients with Hormone ReceptorPositive Advanced Breast Cancer.
RX (1.6 )
Arm A) Exemestane + Entinostat
Arm B) Exemestane + Placebo
_____________________________________________________________________________________________
GASTROINTESTINAL
CARCINOID TUMOR

ALLIANCE A021202 – Prospective Randomized
Phase II Trial of Pazopanib vs Placebo in Patients with
Progressive Carcinoid Tumors
Rx (1.6)
1) Pazopanib
2) Placebo-PD→re-register→Pazopanib
 SWOG S1201-A Randomized Phase II Pilot Study
Prospectively Evaluating Treatment for Patients
Based on ERCC1(Excision Repair Cross
Complementing 1) for Advanced / Metastatic
Esophageal, Gastric or Gastroesophageal Junction
(GEJ) Cancer
Rx (2.5) Rand SWOG S1201 RegSpecStratRand
Rx (0.3) Screen failure
1) FOLFOX
2) CPT-11+ taxo
_________________________________________
GENITOURINARY
PROSTATE
 SWOG S1216 - A Phase III Randomized Trial
Comparing Androgen Deprivation Therapy + TAK-700
with Androgen Deprivation Therapy + Biclutamide in
Patient with Newly Diagnosed Metastatic Hormone
Sensitive Prostate Cancer.
Rx (1.6)
1) LHRHa +TAK 700
2) LHRHa+ Bicalutamide
 ALLIANCE A031201 – Phase III Trial of
Enzalutamide, Abiraterone and Prednisone for
Castration resistant Metastatic Prostate Cancer.
RX (1.6)
1) Enzalutamide
2) Enzalutamide + Abiraterone +
Prednisone
COLORECTAL
RENAL CELL
Prevention
 SWOG S0931 “EVEREST”: Everolimus for Renal
Cancer Ensuing Surgical Therapy, A Phase II Study
Rx (1.6) SWOG S0931
SurgRand
Everolimus/Plac

SWOG S0820 A Double-Blind, Placebo-Controlled
Trial of Eflornithine and Sulindac to prevent
recurrence of High-Risk Adenomas and Second
Primary Colorectal Cancer in Patients with Stage 0-III
colon cancer, Phase III.
CC (1.0) SWOG S0820
1) plac + plac
(Additional $)
2) eflornithine + plac
3) plac + sulindac
4) eflornithine + sulindac
CC (pending) SWOG S0820
Bld banking
 ALLIANCE A031203 - Randomized Phase II Study
Comparing Cabozantinib with Commercially Supplied
Sunitinib in Patients with Previously Untreated
Locally Advanced or Metastatic Renal Cell Carcinoma
Rx (1.6 )
1) Cabozantinib
2) Sunitinib
TRANSITIONAL CELL
Adjuvant
 CALGB 80702- A phase III trial of 6 vs 12 treatments
of adjuvant FOLFOX plus celecoxib or placebo for
patients with resected stage III colon cancer.
Rx (1.6) CALGB 80702
1) FOLFOX x12 + celecoxib/P
2) FOLFOX x6 + celecoxib/P
 CALGB 90601-A randomized double-blinded Phase
III study comparing gemcitabine, Cisplatin, and
Bevacizumab to gemcitabine, cisplatin and placebo in
Patients with Advanced transitional cell carcinoma.
Rx (1.6) CALGB 90601
1) Gem+cp+P
2) Gem+cp+bev
CTSU E1311 - A Randomized, Placebo Controlled
Phase II Trial of Afatinib (BIBW2992) as Adjuvant
Therapy Following Chemoradiation in Patients with
Head and Neck Squamous Cell Carcinoma at High
Risk of Recurrence
Rx (1.0)
1) Afatinib 40mg PO
2) Placebo PO
NRG HN001 – Randomized Phase II and Phase III
Studies of Individualized Treatment of
Nasopharyngeal Carcinoma Based on Biomarker
Epstein Barr Virus (EBV) Deoxyribonucleic Acid
(DNA)
RX (1.6 ) Phase II – Detectable plasma EBV DNA
Arm 1) Cisplatin + 5FU
Arm 2) Gemcitabine + Paclitaxel
Phase III – Undetectable plasma EBV DNA
Arm 3) Cisplatin + 5FU
Arm 4) Observation
______________________________________________
LEUKEMIA
CLL
ECOG-ACRIN E1912 - A Randomized Phase III Study
of Ibrutinib-based Therapy vs Standard Fludarabine,
Cyclophosphamide, and Rituximab (FCR)
Chemoimmunotherapy in Untreated Younger Patients
with CLL
RX (1.6)
1) Ibrutinib + Ritux
2) Ritux + Fludarabine + Ctx
 Alliance A041202 – A Randomized Phase III Study
of Bendamustine + Rituximab vs Ibrutinib + Rituximab
vs Ibrutinib Alone in Untreated Older Patients (> 65
years of age) with Chronic Lymphocytic Leukemia
RX (1.6)
Pre-Reg: Central Review
Rand: 1) Bendamustine + Ritux
2) Ibrutinib
3) Ibrutinib + Ritux
 Companion
Rx (0.5) CALGB 20202
Novel Molecular Markers
CMML
 SWOG S1117- A Randomized Phase II Study of
Azacitidine in Combination with Lenalidomide VS.
Azacitidine Alone VS Azacitidine in Combination with
Vorinostat For Higher-Risk Myelodysplastic
Syndromes and Chronic Myelomonocytic Leukemia.
Rx (2.5) SWOG S1117
1) Azacitidine/ Lenalidomide
2) Azacitidine
3) Azacitidine / Vorinostat
LUNG
NON-SMALL CELL
Alliance A151216 - Adjuvant Lung Cancer
Enrichment Marker Identification and Sequencing
Trial (ALCHEMIST)
RX (0.32)
Screen →FFPE tissue submit
Elig →Register
A) EGFR genetic change →A081105 or
E4512
B) Testing complete but not enrolled→FU
C) Testing/FFPE tiss ueincomplete →
Not enrolled & no FU
RX (0.18)
Biospec tumor blocks (mandatory)
RX (0.04)
Whole Blood (mandatory)
RX (0.02)
Tumor block @ recurrence (mandatory)
Alliance A081105 - Randomized Double Blind
Placebo Controlled Study of Erlotinib or Placebo in
Patients with Completely Resected Epidermal Growth
Factor Receptor (EGFR) Mutant Non-Small Cell Lung
Cancer (ALCHEMIST)
RX (1.6)
Erlotinib/Placebo
ECOG E4512 - A Phase III Double-Blind Trial for
Surgically Resected Early Stage Non-Small Cell Lung
Cancer: Crizotinib Versus Placebo for Patients with
Tumors Harboring the Anaplastic Lymphoma Kinase
(ALK) Fusion Protein (ALCHEMIST)
RX (1.6)
Crizotinib/Placebo
NON-SMALL CELL- ADVANCED
 ECOG E5508 Randomized phase III study of
maintenance therapy with bevacizumab, pemetrexed,
or a combination of bevacizumab and pemetrexed
following carboplatin, paclitaxel and bevacizumab for
advanced non-squamous NSCLC.
Rx (1.0) CTSU E5508
Step 1: Paclit+cbp+bev
Eval:PD→long-term FU
CR/PR/SD→Rand Step 2
Step 2: 1) bev
2) alimta
3) alimta + bev
SQUAMOUS CELL – ADVANCED
SWOG S1400: Phase II/III Biomarker Driven Master
Protocol for Second Line Therapy of Squamous Cell
Lung Cancer.
RX (1.0)
Screening →
No known (+) biomarkers:
A1) MEDI4736
A2) Docetaxel
(+) Biomarker
P13K→B1) GDC-0032
B2) Docetaxel
CDK 4/6→C1) Palbociclib
C2) Docetaxel
EGFR→ D1) AZD4547
D2) Docetaxel
HGF→ E1) Rilotumumab +
Erlotinib
E2) Erlotinib
SMALL CELL
 CALGB 30610- Phase III Comparison of Thoracic
Radiotherapy regimens in Patients with limited small
cell lung cancer also receiving cisplatin and
etoposide.
Rx (1.0) CALGB 30610 1) RT 45 Gy+CP+VP
2) RT 70 Gy+CP+VP
3) RT 61.2 Gy+CP+VP
Re-eval: CR/near CRPCI
CC (0.5) CALGB 30610 QoL
DIFFUSE LARGE B CELL
CTSU E1412: Randomized, Phase II open-label study
of Lenalidomide R-CHOP (R2 CHOP) vs R-CHOP
(Rituximab, Cyclophosphamide, Doxorubicin,
Vincristine and Prednisone) in patients with newly
diagnosed Diffuse Large B Cell Lymphoma.
RX (1.0)
1) Lenalidomide + Ritux + CHOP
2) Rituximab + CHOP
_____________________________________
EXTENSIVE
 RTOG 0937: Randomized Phase II Study
Comparing Prophylactic Cranial Irradiation (PCI)
Alone to PCI plus Consolidative Extra- Cranial
Irradiation for Extensive Disease Small Cell Lung
Cancer (ED-SCLC)
Rx (1.0) RTOG 0937
1) PCI
2) PCI + RT to chest & other ca
Sites
ECOG E2511 - Phase I and Randomized Phase II
Double-Blind Clinical Trial of Cisplatin and Etoposide
in Combination with Veliparib (ABT-888) or Placebo as
Frontline Therapy for Extensive Stage Small Cell Lung
Cancer.
RX (1.6)
D) Veliparib + VP + CP
E) Placebo + VP +CP
CC (0.2)
QOL
MESOTHELIOMA

SWOG S0905- A Phase I / Randomized Phase II
Study of Cediranib Vs Placebo in Combination with
Cisplatin and Pemetrexed in Chemonaive Patients with
Malignant Pleural Mesothelioma.
Rx (1.0) SWOG S0905
Phase I: Completed/closed
(Additional $)
Phase II: Alimta+CP+
Cediranib/Plac
_____________________________________
LYMPHOMA
MANTLE CELL

CTSU E1411 (ECOG) Intergroup Randomized
Phase 2 Four Arm Study in Patients Age 60 or older
with previously untreated Mantel Cell Lymphoma
Rx (2.5) CTSU E1411
Induction (step 1)
A) Ritux + Bendamustine
B) Ritux + Bendamustine +
Bortezumib
5525-05 (08/11/2014)
C) Ritux + Bendamustine
D) Ritux + Bendamustine +
Bortezumib
Eval CR/PR/SDStep 2
E) Ritux
F) Ritux
G) Lenalidomide + Ritux
H) Lenalidomide + Ritux
MELANOMA
ADVANCED
SWOG S1320 – A Randomized Phase II Trial of
Intermittent Versus Continuous Dosing of Dabrafenib
and Trametinib in BRAFV600E/K Mutant Melanoma
RX (1.6 )
Step 1: RX Lead-In
Dabrafenib + Trametinib
Step 2: No dis prog →Rand
1) Dabrafenib + Trametinib
(cont PO)
2) Dabrafenib + Trametinib
(Intermittent PO)
ECOG/ACRIN E3612- A Randomized Phase II Trial of
Ipilimumab With or Without Bevacizumab in patients
with Unresected Stage III or Stage IV Melanoma
RX (1.6)
1) Ipilumuab → Ipilumuab
2) Ipilumuab + Bev →
Ipilumuab + Bev
RX (.12) E3612
Peripheral Blood (opt)
RX (0.8) E3612
Diagnostic tumor block (man)
_____________________________________________
MULTIPLE MYELOMA
CTSU E1A11 – Randomized Phase III Trial of
Bortezomib, Lenalidomide, and Dexamethasone (VRd)
vs Carfilzomib, Lenalidomide, and Dexamethasone
(CRd) followed by Limited or Indefinite duration
Lenalidomide Maintenance in Patients with Newly
Diagnosed Symptomatic Multiple Myeloma.
RX (1.0)
1) Velcade + Revlimid + Dex →
(ECOG)
Revlimid → Observation
(ENDURANCE) 2) Carfilzomib + Revlimid + Dex →
Revlimid
SWOG S1304A Phase II Randomized Study
comparing Two Doses of Carfilzomib with
Dexamethasone for Multiple Myeloma Patients with
Relapsed or Refractory
DiseaseRX (1.0)
1) lo dose carfilzomib → prog
→ Crossover
2) hi dose Carfilzomib
_______________________________________________
CANCER CONTROL
BREAST
SWOG S1202: A Randomized Placebo Controlled
Phase III Study of Duloxetine for Treatment of
Aromatase Inhibitor (AI) – Associated Musculoskeletal
Symptoms in Women with Early Stage Breast Cancer.
CC (1.0)
1) Duloxetine
2) Placebo

CTSU/ECOG E1Z11: A Cohort Study to Evaluate
Genetic Predictors for Aromatase Inhibitor
Musculoskeletal Symptoms (AIMSS)
CC (1.0) CTSU E1Z11
1) Anastrozole
**Cohort for Caucasian women closed
Symptom Management
 URCC 13059: A Geriatric Assessment Intervention
for Patients Aged 70 and Over Receiving
Chemotherapy for Cancer: Reducing Chemotherapy
Toxicity in Older Patients.
CC ( )
1) Physician provided with GA summary
And GA-driven recommendations for
Each enrolled patient prior to treatment.
2) Usual Care
MUCOSITIS
ALLIANCE A221304 – Phase III Placebo-Controlled,
Randomized Three Arm Study of Doxepin and a
Topical Rinse in the treatment of Acute Oral Mucositis
Pain in Patients Receiving Radiotherapy With or
Without Chemotherapy
CC ( )
1) Doxepin (Swish & Gargle & Spit)
2) DLA* (Swish & Gargle & Spit)
3) Placebo (Swish & Gargle & Spit)
* Diphenhydramine HCl, Lidocaine, and antacid susp.
NAUSEA
ALLIANCE A221301 – Olanzapine for the Prevention
of Chemotherapy Induced Nausea and Vomiting
(CINV) in Patients Receiving Highly Emetogenic
Chemotherapy: A Randomized, Double-Blind,
Placebo-Controlled Trial
CC ( )
1) 5-HT3 # + Dex + Fosaprepitant* + Placebo
2) 5-HT3 # + Dex + Fosaprepitant* + Olanzapine
# palonosetron, ondanansetron, or granisetron
* or oral aprepitant
COLORECTAL/ LUNG CANCER
SWOG S1013- A Prospective Study of Epidermal
Growth Factor Receptor (HER-1/EGFR) InhibitorInduced Dermatologic Toxicity: Validation of the
Functional Assessment of Cancer Therapy-EGFRI 18
(FACT-EGFRI 18) Questionnaire for EGFRI- Induced
Skin Toxicities
CC (1.0) SWOG S1013
Sx Questionnaires
REGISTRY STUDY
 LCCC 0916- Phase I Natural History and
Epidemiology for persons over the age of 65.
CC - UNC
QOL / Time get up and go
5525-05 (11/12/2014)