status update 2009

Status Update 2009

Michael J. Fisch, MD, MPH, FACPMedical Director

The Future is NOW

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

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

Option 1Ketoconazole/doxorubicinAlternating withEstramustine/vinblastine

Option 2Prednisone/docetaxel

RANDOMIZE

Sr-89 plus doxorubicin x 6 weeks

Doxorubicin x 6 weeks

Clinical Response

16 weeks

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

Patient Population:

Maximum number of patients is 176. Patients must have a diagnosis of supratentorial glioblastoma multiforme.

109 patients enrolled so far

Treatment: Active

Temozolomide Other Agent(s)

CR,PRorSD

PD

IneligibleCR=complete response, PR=partial response,

SD=stable disease, PD=progressive disease

TMZ-temozolomide; Thal-thalidomide;

CRA-cis-retinoic acid (isotretinoin); Cel-celocoxib

Reg

. &

Ran

do

m.

RT

Max. =5 wks

Sur

gery

or

Bio

psy

1 TMZ None

2 TMZ + Thal

3 TMZ + CRA

4 TMZ + Cel

5 TMZ + Thal/CRA

6 TMZ + Thal/Cel

7 TMZ + CRA/Cel

8 TMZ + Thal/CRA/Cel

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:• Rituximab 375 mg/m2 IVPB on day 1, administered 1st • Cyclophosphamide 750 mg/m2 IVPB on day 1• Pegylated liposomal doxorubicin 40 mg/m2 (maximum dose 90 mg) IV infusion over

1 hr on day 1• Vincristine 2.0 mg IV, day 1• Prednisone 40 mg/m2 P.O. days 1-5• Either GCSF 5 mcg/kg, SC daily, start on day 5, until

neutrophil recovery (absolute neutrophils >3000/ul)• or Pegylated GCSF (Neulasta) 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

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!

Treatment: Active

Study Schema

Week of Study

Day Rituximab1

(mg/m2)GM‑CSF2

(μg)*Exams

and LabsLesion

AssessmentRe‑staging

1‑4 1 375 250 X

3 250

5 250

5‑8 1 250 X X

3 250

5 250

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)

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

• Palliative Care

• Cytokines & Supportive Oncology

• Symptom Science

• Behavioral Medicine

• Integrative Medicine

• Survivorship

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, CanadaLorenzo 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:

• 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

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.


2005-0839 (NCI 7341)A Phase II Study of Gemcitabine, Paclitaxel, and Doxorubicin, with Same-day 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.

Treatment: Active

2006-0198 (NCI MDA 2006-0198)CAM Use and CancerPrincipal Investigator: Patricia Ann Parker, PhD, M. D. Anderson Cancer Center

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.


Baseline Patient Assessment

Random Assignment to Intervention or Waitlist Control

Baseline Provider Assessment

CD/Video and Resource List

Baseline Provider Assessment

Enrollment of Nurses/Providers at Participating CCOPs

CD/Video and Resource List

1 Week

Provider and Patient Follow-Up Assessment Provider and Patient Follow-Up Assessment2 Weeks

Provider and Patient Follow-up Assessment Provider and Patient Follow-up Assessment2 Months

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 ChemotherapyPrincipal 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!


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

Patient Population: The study population will be composed of 300 patients recruited from the outpatient oncology setting. JUST ACTIVATED!


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

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:

CASAD / placebo will be provided by Salient Pharmaceuticals incapsules that are taken as 2 capsules four times daily. EachCASAD 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!


R

6 WeeksCASAD -------------------------- Off Study/Optional Additional 6 Weeks

Placebo -------------------------- Off Study/Optional Additional 6 Weeks

16

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

• Proven to absorb a range of toxins and inflammatory proteins

Calcium Alumino-Silicate

17

Mechanism – Selective Ionic Trapping

• Irinotecan - No chemical reaction (Carpenter, Newman, 2007)

• Trapped chemical bound to CAS in vitro > 99%

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

• 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 (Basen-Engquist)– Enrollment plan is for the CCOPs– R21-funded just this week!!

status update 2009

Documents