Transcript Slide 1

Status Update 2009
Michael J. Fisch, MD, MPH, FACP
Medical Director
The Future is NOW
Treatment: Active
ID00-156 (NCI 3410)
A Prospective Randomized Phase III Trial Comparing Consolidation
Therapy with or without Strontium-89 Following Induction Chemotherapy
in Androgen-Independent Prostate Cancer
Principal Investigator: Shi-Ming Tu, MD, M. D. Anderson Cancer Center
Option 1
Ketoconazole/doxorubicin
Alternating with
Estramustine/vinblastine
Clinical
Response
16 weeks
Option 2
Prednisone/docetaxel
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A
N
D
O
M
I
Z
E
Sr-89 plus doxorubicin x 6 weeks
Doxorubicin x 6 weeks
Patient Population: A total of about 480 patients with androgen-independent prostate cancer will
be accrued for the study. 218 enrolled so far.
Treatment: Active
2004-0662 (NCI 6636)
A Randomized, Factorial-Design, Phase II Trial of Temozolomide Alone and
in Combination with Possible Permutations of Thalidomide, Isotrentinoin
and/or Celecoxib as Post-Radiation Adjuvant Therapy of Glioblastoma
Multiforme
Principal Investigator: Mark R. Gilbert, MD, M. D. Anderson Cancer Center
Temozolomide
1 TMZ
RT
CR,
PR
or
SD
None
2 TMZ + Thal
Reg. & Random.
Surgery or Biopsy
Max. =
5 wks
Other Agent(s)
3 TMZ + CRA
4 TMZ + Cel
5 TMZ + Thal/CRA
6 TMZ + Thal/Cel
PD
7 TMZ + CRA/Cel
Ineligible
CR=complete response, PR=partial response,
SD=stable disease,
PD=progressive disease
8 TMZ + Thal/CRA/Cel
TMZ-temozolomide; Thal-thalidomide;
CRA-cis-retinoic acid (isotretinoin); Cel-celocoxib
Patient Population:
Maximum number of patients is 176.
Patients must have a diagnosis of
supratentorial glioblastoma multiforme.
109 patients enrolled so far
Treatment: Active
2004-0305 (NCI 6485)
A Phase II Study of Rituximab-CHOP with Pegylated Liposomal
Doxorubicin in Patients Older than 60 Years of Age with Untreated
Aggressive B-Cell Non-Hodgkin’s Lymphoma
Principal Investigator: Maria A. Rodriguez, MD, M. D. Anderson Cancer Center
Methodology:
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Rituximab
Cyclophosphamide
Pegylated liposomal doxorubicin
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Vincristine
Prednisone
Either GCSF
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or Pegylated GCSF (Neulasta)
375 mg/m2 IVPB on day 1, administered 1st
750 mg/m2 IVPB on day 1
40 mg/m2 (maximum dose 90 mg) IV infusion over
1 hr on day 1
2.0 mg IV, day 1
40 mg/m2 P.O. days 1-5
5 mcg/kg, SC daily, start on day 5, until neutrophil
recovery (absolute neutrophils >3000/ul)
6 mg SC x1 (24 hours after chemotherapy)
Courses will be repeated every 21 days, provided the absolute neutrophil count is >1000/ul, the platelet count
is >100,000/ul and Troponin I levels are not elevated (> 1.4).
Patient Population: A maximum of 80 patients will be accrued. Patients will be older than 60 years of age
with untreated aggressive B-cell Non-Hodgkin’s Lymphoma. 70 patients enrolled so far.
Treatment: Active
2006-0260 (NCI 7548)
Single-arm, Open-label, Phase II Trial of Rituximab plus Sargramostim for
the Treatment of Newly Diagnosed Follicular B-cell Lymphoma in Adults
Principal Investigator: Peter McLaughlin, MD, M. D. Anderson Cancer Center
Study Schema
Week of
Study
Day
Rituximab1
(mg/m2)
GM-CSF2
(μg)*
Exams
and Labs
1-4
1
375
250
X
5-8
3
250
5
250
1
250
3
250
5
250
Lesion
Assessment
X
Re-staging
X
1.Rituximab should be administered on day 1, 8, 15, & 22.
2.GM-CSF should be administered on day 1, 3, & 5 weekly for 8 weeks (24 doses)
Patient Population: Patients to be enrolled (n=52) in this study will have histologically confirmed, newly
diagnosed follicular B cell lymphoma. 48 enrolled so far!
Cancer Control Trials Dominate
73/83 enrollments in February 2009 were cancer control
The New Model: The M. D. Anderson
Cancer Control CCOP Research Base
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Palliative Care
Cytokines & Supportive Oncology
Symptom Science
Behavioral Medicine
Integrative Medicine
Survivorship
Cancer Control: Active
2004-0024 (NCI CCC01-06)
Chemotherapy and Mindfulness Relaxation: A Randomized Trial at
M. D. Anderson Cancer Center and M. D. Anderson Community Clinical
Oncology Program
Principal Investigators: Jon Hunter MD, FRCP©; Mount Sinai Hospital, Toronto, Canada
Lorenzo Cohen, PhD, M. D. Anderson Cancer Center
Community Co-Investigator: Judith Huber, RN, Marshfield CCOP
Patients with newly-diagnosed cancer, who are about to undergo chemotherapy, and give informed
consent, will be randomly assigned to one of three groups:
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The Mindfulness Relaxation group [MR];
A Relaxing Music group [RM] where participants will listen to music for the same amount of time as
the MR participants receive their intervention;
A Standard Care control group where participants will receive standard medical education on
chemotherapy [SC].
Patient Population: Target accrual 375 subjects, current accrual 136
Cancer Control: Active
2004-0728 (NCI CCC 03-27)
Prevention of Cisplatin- or Oxaliplatin-induced Peripheral Neuropathy with
Alpha-lipoic Acid: A Placebo-controlled Phase III Trial
Principal Investigator: Ying Guo, MD, M. D. Anderson Cancer Center
Week
6±1
*Stratum
1
2
3
Total Prior
Cisplatin Rx*
<200 mg/m2
200-399 mg/m2
>400 mg/m2
Week
12±1
Total Prior
Oxaliplatin Rx*
<750 mg/m2
750-999 mg/m2
>1000 mg/m2
*For patients previously exposed to both drugs,the
following formula will be used. If “X mg/m2” of
Cisplatin and “Y mg/m2” of oxaliplatin had been
received, a “calculated prior cisplatin dose”, Z, will
be used for stratification in the cisplatin column.
Z=Y/3 + X
TID
Week
24±1
No treatment
No treatment
No treatment
Week 36 ±1
**Functional Tests
• Time to button 6-hole shirt
• 50-foot walk at fastest speed
• Coin test
Chemotherapy cycles most likely
will be received by patients
Chemotherapy cycles possibly will
be received by patients
FACT/GOG-NTX, BPI, Functional Tests**
TID
Placebo
No treatment
FACT/GOG-NTX, BPI, Functional Tests**
TID
Placebo
ALA
600 mg
TID
FACT/GOG-NTX, BPI, Functional Tests**
Placebo
ALA
600 mg
TID
FACT/GOG-NTX, BPI, Functional Tests**
ALA
600 mg
TID
FACT/GOG-NTX, BPI, Functional Tests**
Randomization*
FACT/GOG-NTX, BPI, Functional Tests**
Platinum Therapy
(Schema overview for CCOP patients enrolled)
Week 48 ±1
Patient Population:
This study will enroll both
male and female patients,
who plan to receive
chemotherapy that contains
platinum in their regimen.
Patients will receive
treatment in an outpatient
setting. The study is a
randomized, double-blind,
phase III trial, with 85
evaluable patients assigned
to each of the two treatment
groups. A total of 244
patients will be accrued, and
191 enrolled so far.
Treatment: Active
2005-0839 (NCI 7341)
A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, with Sameday Pegfilgrastim for the Treatment of Patients with Metastatic Transitional
Cell Carcinoma and Renal Insufficiency
Principal Investigator: Lance C. Pagliaro, MD, M. D. Anderson Cancer Center
Methodology:
In this single-arm phase II protocol, patients with creatinine clearance < 60 ml/min will receive
doxorubicin plus paclitaxel and gemcitabine. Treatment will be administered on an outpatient
basis. All patients will receive: doxorubicin 40 mg/m2 IV over 20 min; paclitaxel 135 mg/m2 IV
over 60 min; gemcitabine 900 mg/m2 IV over 90 min; repeat every 14 days. All patients will
receive pegfilgrastim 6 mg SC on day 1 or day 2 of each course.
Patient Population: Patients to be enrolled in this study (n = 72) must have histologically or
cytologically confirmed metastatic or unresectable transitional cell (TCC) carcinoma of bladder,
urethra or upper urinary tract. Mixed TCC and variant histologies (small cell, squamous,
adenocarcinoma, sarcoma) are permitted if present in < 50% of the biopsy specimen.
Cancer Control: Active
2006-0198 (NCI MDA 2006-0198)
CAM Use and Cancer
Principal Investigator: Patricia Ann Parker, PhD, M. D. Anderson Cancer Center
Random Assignment to Intervention or Waitlist Control
Enrollment of Nurses/Providers at Participating CCOPs
1 Week
Baseline Patient Assessment
Baseline Provider Assessment
Baseline Provider Assessment
CD/Video and Resource List
Provider and Patient Follow-Up Assessment
2 Weeks
Provider and Patient Follow-Up Assessment
Provider and Patient Follow-up Assessment
2 Months
Provider and Patient Follow-up Assessment
CD/Video and Resource List
Patient Population: The study population will be composed of oncology nurses/providers who have consented to participate in this
study at each individual participating CCOP site that has agreed to take part in this study. 185 enrolled of 680 target accrual.
Cancer Control: Active
2006-0841 (NCI MDA 2006-0841)
Randomized, Double-Blind, Placebo-Controlled Trial of Palonosetron/
Dexamethasone with or without Dronabinol for the Prevention of
Chemotherapy-induced Nausea and Vomiting after Moderately Emetogenic
Chemotherapy
Principal Investigator: Steven Grunberg, MD, University of Vermont Hematology/Oncology Unit,
Burlington, Vermont
Co-PI:
Michael J. Fisch, MD, M. D. Anderson CCOP Research Base
Community Co-Investigator: Jeffery Giguere, MD, Greenville CCOP, Greenville, South Carolina
Methodology:
All patients receive palonosetron 0.25 mg IV and dexamethasone 10 mg IV 30 minutes prior to administration of
chemotherapy. Patients are randomized to take dronabinol 5 mg or matched placebo: 1 tablet by mouth 3 times a
day for 5 days beginning 30 minutes before chemotherapy. Blood tests and informed consent prior to start of therapy.
Patients will answer the modified MANE instrument questions day 1 through 5 after the administration of
chemotherapy as well as keep a daily diarrhea diary.
There will be a follow-up physical examination and assessment between day14 through 28. The primary endpoint
will be Total Protection: No Vomiting, No Rescue Therapy and no nausea during the overall (0-120 hour) period. The
secondary endpoints will be No Vomiting, No Significant Nausea, No Nausea, Complete Protection and Complete
Response evaluated for the Acute (0-24 hour), Delayed (24-120 hour), and Overall (0-120 hour) periods.
Patient Population: The study population will be composed of 100 patients in each treatment group (200 patients
total). Patients will be 18 years old or older, have a histologically or cytologically documented solid tumor and be
receiving chemotherapy for the first time. JUST OPENED!
Cancer Control: Active
2007-0791 (NCI MDA 05-08-04)
A Randomized Comparison of Oral Methadone as a “First-Switch” Opioid
versus Opioid Switching Between Sustained-Release Morphine and
Oxycodone for Oncology-Hematology Outpatients with Pain Management
Problems: The “Simply Rotate” Study
Principal Investigator: Michael J. Fisch, MD, M. D. Anderson CCOP Research Base
Oncology outpatient with chronic pain requiring long-acting, strong opioid analgesic such as morphine, hydromorphone,
oxycontin, or transdermal fentanyl AND: Persistent pain ≥ 5/10 in severity at its worst OR one or more persistent and
bothersome opioid side effects such as constipation, nausea, sedation/mental clouding or myoclonus.
Consent & Registration
Calculate the morphine oral equivalent daily dose (MEDD) of the currently used strong opioid(s)
RANDOMIZATION
Switch to oral methadone-based
opioid regiment
Switch to another strong opioid
(not methadone)
Telephone assessments (or face-to-face assessments) for pain relief and toxicity on Days 8, 15, and 22
Study completion visit on Day 28 (+/- 3 days) to assess the primary endpoint
Patient Population: The study population will be composed of 300 patients recruited from the outpatient oncology
setting. JUST ACTIVATED!
Cancer Control: Active
2008-0005 (NCI MDA 2008-0005)
Phase II, Randomized, Double Blind Comparison of CASAD vs. Placebo for
the Treatment and Prevention of Diarrhea in Patients with Metastatic
Colorectal Cancer
Principal Investigator: Katrina Glover, MD, M. D. Anderson Cancer Center
Methodology:
R
6 Weeks
CASAD -------------------------- Off Study/Optional Additional 6 Weeks
Placebo -------------------------- Off Study/Optional Additional 6 Weeks
CASAD / placebo will be provided by Salient Pharmaceuticals in
capsules that are taken as 2 capsules four times daily. Each
CASAD capsule contains 500 mg HCAS. Placebo will be provided in a similar color
and shape as CASAD. A 2-hour window will be required between administration of
CASAD/placebo and all other medications. CASAD / placebo should be started at
least one hour prior to receiving chemotherapy.
Patient Population: A maximum of 100 patients will be randomized equally between two arms,
50 per arm. JUST ACTIVATED!
The Product
• Calcium Alumino-Silicate (CAS)
based pharmaceutical
– Administered in capsules, tablets and
oral suspension dose form
• Raw material is a naturally
occurring mineral
– No dioxins, heavy metals at limits of
detection
• GRAS substance, FDA approved
food and feed additive
Calcium Alumino-Silicate
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Mechanism – Selective Ionic
Trapping
• Irinotecan - No chemical reaction (Carpenter, Newman, 2007)
• Trapped chemical bound to CAS in vitro > 99%
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Coming Attractions
• PREDICT study: using biomarkers to detect
and identify cardiotoxicity in patients
receiving anthracyclines
– Concept approved, protocol being submitted
– Cardiology & Oncology Partnership
Coming Attractions
• Trimethoprim-EDTA to prevent CVC-catheter
occlusions (Raad)
– We have previously presented information concerning the protocol “Prospective,
Randomized Trial Comparing Heparin and Minocycline-EDTA Flush for the Prevention
of Catheter-Related Infections and Occlusions.” The protocol was NCI-approved. Now
we will be modifying this protocol to compare trimethroprin-EDTA in 25% ethanol with
saline. We will resubmit to the NCI. Great Lakes Pharmaceuticals (GLP), the sponsor, is
preparing to manufacture the supply kits that will be used during the conduct of this trial
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Questions for you
– Which catheters do you use?
– Heparin vs. saline for flush? Lock?
– Simultaneous (peripheral and CVC) drawn blood cultures—is it feasible for you?
Coming Attractions
• Oncologist-Assisted Home Exercise Program
for Advanced Colon Cancer Patients (BasenEngquist)
– Enrollment plan is for the CCOPs
– R21-funded just this week!!