At Front Range Cancer Specialists, we feel that research
is critical to the advancement od cancer therapy. We actively participate
in large, cooperative group trials such as Eastern Cooperative Oncology
Group (ECOG), North Central Cancer Treatment Group (NCCTG), Cancer and
Leukemia Group B (CALGB), Radiation Therapy Oncology Group (RTOG), National
Surgical Adjuvant Breast and Bowel Project (NSABP), Cancer Trials Support
Unit (CTSU)/Southwest Oncology Group (SWOG) and Gynecological Oncology
Group (GOG). We also have several pharmaceutical-based trials available
through our office. The following is a list of our active protocols
by topic. For further information, please feel free to contact
us.
NCCTG 94-72-52 Diagnostic and Prognostic Markers
in Anaplastic Astrocytoma and Anaplastic Oligoastrocytoma
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Adjuvant: DCIS
NSABP B-35 A Clinical Trial Comparing Anastrozole With
Tamoxifen in Postmenopausal Patients With Ductal Carcinoma In Situ (DCIS)
Undergoing Lumpectomy With Radiation Therapy
I: Tamoxifen 20 mg/day + placebo (anastrozole look-alike)
x 5 yrs + RT
II: Anastrozole 1mg/day + placebo (Tamoxifen look-alike) x 5 yrs +
RT
Adjuvant: Receptor Positive
CTSU / IBCSG 24-02 A Phase III Trial of Evaluating the
Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant
Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
I: Tamoxifen 20mg/day x 5 years
II: ovarian function suppression + Tamoxifen 20mg/day x 5 years
III: ovarian function suppression + Exemestane 25mg/day x 5 years
***ovarian function suppression = triptorelin x 5 yrs OR
surgical oophorectomy OR ovarian irradiation***
CTSU / NCIC MA.27 A Randomized Phase III Trial of
Exemestane Versus Anastrozole With or Without Celecoxib in Postmenopausal
Women With Receptor Positive Primary Breast Cancer
I: Exemestane 25mg/day x 5 yrs ***no substitutions w/ Tamoxifen
allowed***
II: Anastrozole 1mg/day x 5 yrs ***no substitutions w/ Tamoxifen allowed***
Adjuvant: Node Negative
NSABP B-36 A Clinical Trial of Adjuvant Therapy Comparing
Six Cycles of 5-FU, Epirubicin and Cyclophosphamide (FEC) to Four
Cycles of Adriamycin and Cyclophosphamide (AC), With or Without Celecoxib,
in Patients With Node-Negative Breast Cancer
I: AC q 21 days x 4 cycles + Hormonal Therapy x 5 yrs
III: FEC q 21 days x 6 cycles + Hormonal Therapy x 5 yrs
N9831 Phase III Trial of Doxorubicin and Cyclophosphamide
(AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as
Adjuvant Treatment for Women With HER-2 Over-expressing or Amplified
Node Positive or High-Risk Node Negative Breast Cancer
I: AC (q 21 days) x 4 cycles > Taxol (q wk) x 12 cycles
II: AC (q 21 days) x 4 cycles > Taxol (q wk) x 12 cycles > Herceptin
x 52 weeks
III: AC (q 21 days) x 4 cycles > Taxol + Herceptin (q wk) x 12 cycles
> Herceptin x 40 weeks
Adjuvant: Node Positive
NSABP B-38 A Phase III, Adjuvant Trial Comparing Three Chemotherapy
Regimens in Women With Node-Positive Breast Cancer: Docetaxel/Doxorubicin/Cyclophosphamide
(TAC); Dose Dense (DD) Doxorubicin/Cyclophosphamide Followed by Paclitaxel
(DD AC> P); DD AC Followed by DD Paclitaxel Plus Gemcitabine (DD AC>
PG)
I: TAC (q 21 days) x 6 cycles
II: AC (q 14 days) x 4 cycles > Taxol (q 14 days) x 4 cycles
III: AC (q 14 days) x 4 cycles > Taxol + Gemzar (q 14 days) x 4 cycles
NSABP B-31 A Randomized Trial Comparing the Safety
and Efficacy of Adriamycin and Cyclophosphamide Followed by Taxol
(AC > T) to that of Adriamycin and Cyclophosphamide Followed by Taxol
Plus Herceptin (AC > T + H) in Node-Positive Breast Cancer Patients
Who Have Tumors that Over Express HER2, Phase III
I: AC (q 21 days) x 4 cycles > Taxol (q 21 days) x 4 cycles
II: AC (q 21 days) x 4 cycles > Taxol (q 21 days) x 4 cycles + Herceptin
x 52 weeks
N9831 Phase III Trial of Doxorubicin and Cyclophosphamide
(AC) Followed by Weekly Paclitaxel With or Without Trastuzumab as
Adjuvant Treatment for Women With HER-2 Over-expressing or Amplified
Node Positive or High-Risk Node Negative Breast Cancer
I: AC (q 21 days) x 4 cycles > Taxol (q wk) x 12 cycles
II: AC (q 21 days) x 4 cycles > Taxol (q wk) x 12 cycles > Herceptin
x 52 weeks
III: AC (q 21 days) x 4 cycles > Taxol + Herceptin (q wk) x 12 cycles
> Herceptin x 40 weeks
Advanced / Metastatic
N0336 Phase II Trial of Raf Kinase Inhibitor BAY 43-9006
as Single Oral Agent in Patients with Metastatic Breast Cancer Previously
Exposed to Anthracycline and/or Taxane
Tx: BAY 43-9006 400mg po bid until progression
N0432 Phase II Trial of Docetaxel with Capecitabine
and Bevacizumab as First Line Chemotherapy for Patients with Metastatic
Breast Cancer
Tx: Docetaxel 75mg/m2 (D1) + Bevacizumab
15mg/kd (D1) + Capecitabine 825mg/m2 po bid (D1-14) q 21
days until progression
E4101 A Phase II Trial of Combination Anastrozole
plus ZD1839 (Iressa) and of Combination Fulvestrant plus Iressa in
the Treatment of Postmenopausal Women With Hormone Receptor-Positive
Metastatic Breast Cancer
I: Anastrozole 1mg po qd + Iressa 500mg's po qd until progression
II: Fulvestrant 250mg i.m. injection q 4 wks + Iressa 500mg's po qd
until progression
Gastrointestinal
Anal
ECOG / R9811 A Phase III Randomized
Study of 5-Fluorouracil, Mitomycin-C, and Radiotherapy vs 5-Fluorouracil,
Cisplatin, and Radiotherapy in Carcinoma of the Anal Canal (T2-4,
any N stage, M0)
I: MMC (D 1, 29) + 5-FU (D 1-4, 29-32) + concurrent RT x
6.5 wks
II: Cisplatin (D 1, 29, 57, 85) + 5-FU (D 1-4, 29-32, 57-60, 85-88)
+ RT x 6.5 wks starting at day 57 of 5-FU
NSABP P-3 Celecoxib Polyp Prevention Trial in Participants
With Resected Stage I Colon Cancer
I: Placebo po bid x 3 yrs
II: Celebrex 400mg po bid x 3 yrs
TEMPORARY CLOSURE 12/17/04 DUE TO CELEBREX RISKS
Adjuvant
NSABP C-08 A Phase III Clinical Trial Comparing Continuos
Infusion of 5-Fluorouracil, Leucovorin, and Oxaliplatin (mFOLFOX6) Every
Two Weeks With Bevacizumab to the Same Regimen Without Bevacizumab For
the Treatment of Patients With Resected Stages II and III Carcinoma
of the Colon
I: mFOLFOX6* q 14 days x 12 cycles (*5-FU given bolus day
1 and then IV continuos infusion for 46 hours*)
II: mFOLFOX6* + Bevacizumab q 14 days x 12 cycles > Bevacizumab q
14 days x 6 months
N0147 A Randomized Phase III Trial of Irinotecan
and / or Oxaliplatin + 5FU / Leucovorin With or Without Cetuximab
After Curative Resection for Patients With Stage III Colon Cancer
I: FOLFOX q 2 wks x 12 cycles
II: FOLFIRI q 2 wks x 12 cycles
III: FOLFOX q 2 wks x 6 cycles > FOLFIRI q 2 wks x 6 cycles
IV: FOLFOX q 2 wks x 12 cycles + C225 (D1, 8) x 12 cycles
V: FOLFIRI q 2 wks x 12 cycles + C225 (D1, 8) x 12 cycles
VI: FOLFOX q 2 wks x 6 cycles + C225 (D1, 8) x 6 cycles > FOLFIRI
q 2 wks x 6 cycles + C225 (D1, 8) x 6 cycles
NSABP R-04 A Clinical Trial Comparing Preoperative
Radiation Therapy and Capecitabine with Preoperative Radiation Therapy
and Continous Infusion of 5-FU in the Treatment of Patients with Operable
Carcinoma of the Rectum
I: RT + 5-FU
II: RT + Capecitabine
E3201 Intergroup Randomized Phase III Study of Postoperative
Irinotecan, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Fluorouracil
and Leucovorin vs 5-Fluorouracil and Leucovorin for Patients with
Stage II or III Rectal Cancer Receiving Either Preoperative Radiation
and 5-Fluorouracil or Postoperative Radiation and 5-Fluorouracil
Tx: MD to decide between pre/post op chemo + XRT;
please see study schema for randomization arms A-F
TEMPORARY CLOSURE 11/26/04 -- STUDY BEING
REDESIGNED
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(none)
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Liver
E1203 A Phase II Study of ZD1839 (Iressa) in Advanced
Hepatocellular Carcinoma
Tx: Iressa 250mg po qd until progression
TEMPORARY SUSPENSION 8-16-04 (ACCRUAL MET FOR
TREATMENT RESPONSE EVALUATION)
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CTSU / S0205 A Phase III Randomized Open-Label Study
Comparing Gemcitabine Plus Cetuximab (IMC-C225) versus Gemcitabine
as First-Line Therapy of Patients with Advanced Pancreas Cancer
I: Gemzar 1000mg/m2 (D1, 8, 15) + Cetuximab 250mg/m2
(D1, 8, 15, 22) q 4 wks until progression
II: Gemzar 1000mg/m2 (D1, 8, 15) q 4 wks until progression
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Genitourinary
Bladder
CTSU / CALGB 90104 A Randomized Phase III Study Comparing
Sequential Chemotherapy (AG-TP) to Cisplatin and Gemcitabine (GC)
as Adjuvant Treatment After Cystectomy for Transitional Cell Carcinoma
of the Bladder
I: Gemzar 1000mg/m2 (D1, 8, 15) + Cisplatin 60mg/m2
(D1) q 4 wks x 4 cycles
II: Adria (D1) + Gem (D1) + GCSF (D3-10) q 2 wks x 4 cycles ¨ Taxol (D1) + Cisplatin (D1) + GCSF (D3-10)
q 2 wks x 4 cycles
Germ Cell
CTSU / CALGB 90106 A Randomized Phase III Study of Paclitaxel,
Ifosfamide and Cisplatin vs Vinblastine, Ifosfamide and Cisplatin
as Second-Line Therapy for Patients With Relapsed/Resistant Germ Cell
Tumors
I: Taxol (D1) + Ifosfamide (D2-5) + Cisplatin (D2-5) q 21
days x 4 cycles
II: Vinblastine (D1-2) + Ifosfamide (D1-5) + Cisplatin (D1-5) q 21
days x 4 cycles
Prostate
S0000A Prevention of Alzheimer's Disease with Vitamin
E and Selenium (PREADVISE), Phase III Ancillary to S0000 (SELECT)
Ancillary to SELECT, mental status exams
Renal
CTSU / C90206 A Randomized Phase III Trial of Interferon Alfa-2B or
Interferon Alfa-2B Plus Bevacizumab in Patients With Advanced Renal
Carcinoma
I: Interferon alfa-2b 9.0 MU 3 times per wk x 4 wks
II: Interferon alfa-2b 9.0 MU 3 times per wk x 4 wks + Bevacizumab
(D 1, 15) q 4 wks
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(none)
Refractory
CTSU / G0198 A Randomized Study of Tamoxifen vs Thalidomide
in Patients With Biochemical-Recurrence Only Epithelial Ovarian Cancer,
Cancer of the Fallopian Tube, and Primary Peritoneal Carcinoma After
First Line Therapy
I: Tamoxifen 20mg bid until progression
II: Thalidomide 400mg qd until progression
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E3301 Phase II Trial of Weekly Irinotecan and Docetaxel
in Recurrent or Metastatic Head and Neck Carcinoma
Tx: Docetaxel 35 mg/m2 (D 1, 8) + Irinotecan
60 mg/m2 (D 1, 8) until progression
CHEMO EXPOSED STRATUM CLOSED 8/6/04 (ACCRUAL
GOAL MET)
CHEMO NÁVE STRATUM TEMPORARILY SUSPENDED
5/23/03 (PENDING RESPONSE EVAL)
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AML
CTSU / C10201 A Phase III Study of Daunorubicin and Cytarabine
+/- G3139 (Genasense
TM, Oblimersen Sodium, NSC # 683428,
IND # 58842), a BCL2 Antisense Oligodeoxynucleotide, in Previously Untreated
Patients With Acute Myeloid Leukemia
I: Remission Induction (10 days): G3139 + Cytarabine + Daunorubicin
> BMBx (day 17)
A. if complete response
> Consolidation Therapy: G3139 + High Dose Cytarabine (8 days x 2
cycles)
B. if not complete
response > 2nd Induction with same drugs (8 days) > BMBx
(w/in 1 wk of ANC > 1500u/l) > if complete response, see
"A", if not complete response, patient removed from tx and
followed
II: Remission Induction (7 days): Cytarabine + Daunorubicin
> BMBx (day 14)
A. if complete response > Consolidation Therapy: High
Dose Cytarabine (5 days x 2 cycles)
B. if not complete response > 2nd Induction with
same drugs (5 days) > BMBx (w/in 1 wk of ANC > 1500u/l)
> if complete response, see "A", if not complete response,
patient removed from tx and followed
APL
ECOG / C9710 Phase III Randomized Study of Concurrent Tretinoin
and Chemotherapy with or without Arsenic Trioxide (AS203) (NSC # 706363)
as Initial Consolidation Therapy Followed by Intermittent Tretinoin
Maintenance Therapy versus Observation for Patients with Untreated Acute
Promyelocytic Leukemia
I: ATRA + Ara-C + Daunorubicin > Evaluation > ATRA + Daunorubicin
(x 2 cycles) > Randomization to:
A: ATRA + 6-MP + Mtx x 1 year
B: ATRA q other wk x 1 year
II: ATRA + Ara-C + Daunorubicin > AS2O3
(D1-5) x 5 wks x 2 cycles > ATRA + Daunorubicin (x 2 cycles) > Randomization
to:
A: ATRA + 6-MP + Mtx x 1 year
B: ATRA q other wk x 1 year
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Ancillary Studies
S9925 Lung Cancer Specimen Repository Protocol, Ancillary
Small Cell: Extensive
E3501 A PhaseII Study of Cisplatin Plus Etoposide Plus
Bevacizumab for Previously Untreated Extensive Stage Small Cell Lung
Cancer
Tx: Cisplatin (D1) + Etoposide (D1-3) + Bevacizumab (D1)
q 21 days x 4 cycles > Bevacizumab (q 21 days) up to one year
Non-Small Cell: Adjuvant / Resected
CTSU / NCIC BR.19 A Phase III Prospective Randomized, Double-Blind,
Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist,
ZD1839 (Iressa) in Completely Resected Primary Stage IB, II, and IIIA
Non-Small Cell Lung Cancer
***Post-op platinum based chemotherapy allowed and regimen
up to investigator. Post-op RT also allowed.***
I: Iressa 250 mg po qd x 2 years
II: Placebo po qd x 2 years
Non-Small Cell: Advanced / Metastatic
N0222 Parallel Phase II Trials of ZD1839 (Iressa) Alone or Weekly
Carboplatin and Paclitaxel Followed by ZD1839 (Iressa) (Oncologists
Must Choose) for Metastatic Non-Small Cell Lung Cancer in Patients
>
65 Years of Age
I: Iressa 250mg's qd po until progression
II: Taxol + Carboplatin (D1, 8, 15) q 28 days x 4 cycles > Iressa
250mg's qd po until progression
N0323 A Phase II Study of the mTOR Inhibitor, CCI-779
in Patients with Advanced NSCLC
Tx: CCI-779 25mg IV (D1, 8, 15, 22) q 28 days until
progression
NCCTG / S0023 A Phase III Trial of Cisplatin/Etoposide/Radiotherapy
with Consolidation Docetaxel Followed by Maintenance Therapy with
ZD1839 or Placebo in Patients with Inoperable Locally Advanced Stage
III Non-Small Cell Lung Cancer
Cisplatin (D1, 8, 29, 36) + Etoposide (D1-5, 29-33) q 28
days x 2 cycles + Radiation x 6.5 wks > Taxotere (q 21 days) x 3 cycles
> Randomized to either:
I: Maintenance Therapy with Iressa daily x 5 years
II: Maintenance Therapy with Placebo daily x 5 years
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Lymphoma
Hodgkin's: Advanced
E2496 A Randomized Phase III Trial of ABVD vs Stanford
V +/- Radiation Therapy in Locally Extensive and Advanced Stage Hodgkin's
Disease
I: ABVD (D1, 15) q 28 days x 6 - 8 cycles > RT (if needed)
II: Stanford V x 12 wks > RT (if needed)
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Mesothelioma
(none)
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Multiple Myeloma
E2A02 A Phase II Study of PS-341 for Patients with
High-Risk, Newly Diagnosed Multiple Myeloma
Tx: Induction: PS-341 1.3mg/m2 (D1, 4,
8, 11) q 21 days x 8 cycles > Maintenance: PS-341 1.3mg/m2
(D1, 15) q 28 days until progression > Reinduction: PS-341 1.3mg/m2
(D1, 4, 8, 11) q 21 days until 2nd progression
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Myelodysplastic Syndrome
& Myeloid Metaplasia
(none)
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Sarcoma
GIST
CTSU / ACOSOG Z9001 A Phase III Randomized Double-Blind
Study of Adjuvant STI571 (Gleevec) versus Placebo in Patients following
the Resection of Primary Gastrointestinal Stromal Tumor (GIST)
I: Placebo x 1 year > if recurrence > STI-571 400 mg qd
x 2 years > Follow Up
II: STI-571 400 mg qd x 1 year > Follow Up > if recurrence > STI-571
400 mg qd x 2 years > Follow Up
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Skin
High-Risk
ECOG / S0008 Phase III Trial of High-Dose Interferon Alpha-2b
Versus Cisplatin, Vinblastine, DTIC Plus IL-2 and Interferon in Patients
with High-Risk Melanoma
I: One-Year High Dose Interferon Alpha-2b
II: Cisplatin + DTIC + Vinblastine + IL-2 + Interferon Alfa-2b + GCSF
(q 21 days) x 3 cycles
Advanced / Metastatic
E4697 A Randomized, Placebo-Controlled Phase III Trial of Yeast Derived
GM-CSF Versus Peptide Vaccination Versus GM-CSF Plus Peptide Vaccination
Versus Placebo in Patients with "No Evidence of Disease" after
Complete Surgical Resection of "Locally Advanced" and/or Stage
IV Melanoma
I: GM-CSF + Peptide Vaccination
II: GM-CSF Placebo + Peptide Vaccination
III: GM-CSF + Peptide Placebo
IV: GM-CSF Placebo + Peptide Placebo
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Cancer Control / Miscellaneous
Studies
N03CB An Exploratory, Placebo Controlled Trial of
Prophylactic Tetracycline for Gefitinib or Cetuximab Induced Skin
Rash (or Other Epidermal Growth Factor Receptor (EGFR) Inhibitor Induced
Skin Rash)
I: Tetracycline 500mg bid x 4 wks
II: Placebo bid x 4 wks
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