Primary Site / Sponsor

Oncotype score used to determine treatment assignment

CIRB
ECOG PACCT-1
TAILORx

Medical Oncology

Protocol Description

Trial Assigning Individualized Options for Treatment using Oncotype DX assay Recurrent Score (RS 11-25 are randomized to Chemo + hormonal therapy OR hormonal therapy only: <11 receive only hormonal therapy and > 25 receive chemo + hormonal therapy)

Eligibility

• ER+ and/or PR+
• Her2/nue not over expressed
• Axillary node negative and age <75 yrs
• Tumor 1.1 to 5 cm or 5 mm -1cm and unfavorable histological features
• Treatment with MammoSite excludes patient

Primary Site / Sponsor

Chemotherapy 1st line

CIRB
ECOG 5103

Medical Oncology

Protocol Description

Double blind Phase III Trial of Doxirubicin and Cyclophosphomide followed by Paclitaxel with Bevacizumad or Placebo in Pts with Lymph node Positive and High Risk Lymph Node Negative Breast Cancer

Eligibility

• Patient must meet at least one of the following A) at least one positive axillary lymph node; B) ER negative tumor ≥ 1cm; C) ER +  node ≥ 5 cm; D) ER + ≥ 1 cm but < 5cm with RS of ≥ 11 (ok if enrolled in TAILORx  Study)
• Her2/neu expression excludes patient
• H/o recent MI or significant cardiac history excludes patient

Primary Site / Sponsor

Lymphedema Prevention Study

CALGB 70305

Protocol Description

A Randomized Study to Prevent Lymphedema in Women Treated for Breast Cancer

Eligibility

Step 1

• Female newly diagnosed with Stage I-III breast cancer
• No previous h/o carcinoma in situ, LCIS, DCIS or invasive breast ca
  • Patient with other invasive cancers are eligible if they have completed treatment at least 5 years ago. Patient with basal cell and squamous cell cancer of the skin are eligible
• Be scheduled for surgery as part of their treatment
• Patient scheduled to receive radiation to the breast or axilla are eligible but must have measurements taken before neoadjuvant treatment
• Patient scheduled for neoadjuvant chemotherapy must be registered to the study with pre-surgery measurements taken prior to starting neoadjuvant treatment
• No h/o conduction disturbances, unstable angina, dementia or other chronic illness
• Eligible patients must have their arm measurements of axilla, elbow and wrist fall into one of the six sleeve sizes
• Be at least 18 years old
• No previous diagnosis of lymphedema

Step 2

• Full axillary node dissection (AND) of  ten or more nodes
  • Patient with AND of less than 10 nodes may also be eligible, after review of pathology  and operative reports by Study MD
• Patients with only sentinel nodes removed are Not eligible
  • Patient with double mastectomies, bil axillary node dissection and /or radiation to both arms are not eligible

Primary Site / Sponsor

Neuropathy Prevention Study

SWOG
S0715

Protocol Description

Phase III Randomized Study of Acetyl-L-Carnitine  Hydrochloride versus Placebo in the Prevention of Neuropathy in Women With Stage I, II or III Cancer Undergoing Adjuvant Taxane-Based Chemotherapy

Eligibility

• Histologically confirmed primary invasive adenocarcinoma of the breast
• Stage I-IIIA  disease
• No metastatic disease
• Must have undergone modified radical mastectomy or breast-sparing surgery
• Planning to receive standard taxane-based systemic chemotherapy adjuvant therapy
• No history of neuropathy
• ECOG PS 0-2

Primary Site / Sponsor

Adjuvant post Herceptin therapy

Wyeth Pharmaceuticals
3144A2-3004-WW

Medical Oncology

Protocol Description

A Randomized Double- Blind Placebo-Controlled Trial of Neratinib (HKI-272) After Trastuzumab in Women with Early Stage HER 2/neu Overexpressed/ Amplified Breast Cancer

Eligibility

• Female age 18 years or older
• Confirmed primary adenocarcinoma of the breast that is erb-2 positive
• Subject must be adequately treated with surgery, mastectomy or lumpectomy and sentinel node dissection if indicated
• Stage I through 3c primary breast cancer
• Must have completed course of adjuvant trastuzumab. Patients who received partial treatment may also qualify
• Last dose of trastuzumab must have been given > 2 weeks and ≤1 year from randomization

Primary Site / Sponsor

HER2/neu Positive Metastatic Breast Cancer

Wyeth Pharmaceuticals 3144A2-3005-WW

Medical Oncology

Protocol Description

This Phase III study is investigating the effects of an experimental drug (neratinib) in combination with paclitaxel versus trastuzumab in combination with paclitaxel for the treatment of women who have not received previous treatment for erbB-2-positive locally recurrent or metastatic breast cancer.

The study will compare the effectiveness of each regimen in shrinking tumors and extending the lives of women with erbB-2 (HER2) positive breast cancer. The study will also compare the safety of the two regimens and as well as the quality of life of subjects receiving either regimen.

Eligibility

• Female subjects aged 18 years and older
• Locally recurrent or metastatic breast cancer that is not amenable to curative surgery and/ or radiation
• Documentation of erbB-2 gene amplification by FISH
• ECOG status of 0 to 2
• Exclusion criteria:
  1. Prior systemic anti-cancer therapy other than endocrine therapy for locally recurrent or metastatic disease.
  2. Prior erbB-2 inhibitor other than trastuzumab or lapatinib in the neoadjuvant or adjuvant setting.
  3. Progression/recurrence w/in 12 months after completion of adjuvant or neoadjuvant therapy.
  4. History of heart disease
  5. History of gastrointestinal disease

Primary Site / Sponsor

Rectal 1st line

CIRB
NSABP R-04

Medical Oncology/Radiation Oncology

Protocol Description

A Clinical Trial Comparing Preoperative RT and Xeloda w/ or w/o Oxaliplatin with Preoperative Radiation Therapy and CI 5-FU w/ or w/o Oxaliplatin in Patients with Operable Carcinoma of the Rectum

Eligibility

• Adenocarcinoma of rectum; amenable to surgical resection; <12cm from anal verge
• Stage II T3-4N0 or Stage III T1-4N1-2
• Interval between diagnosis and randomization < 42 days
• Tumor palpable by rectal exam

Primary Site / Sponsor

COLON

ECOG
E5202

Medical Oncology

Protocol Description

A Randomized Phase III Study Comparing 5-FU, Leucovorin and Oxaliplatin versus 5-FU, Leucovorin, Oxaliplatin and Bevacizumab in Patients with Stage II Colon Cancer at High Risk for Recurrence to Determine Prospectively the Prognostic Value of Molecular Markers

Eligibility

• Patient must have histologically confirmed adenocarcinoma of the colon that is Stage II disease (T3,4N0M0)
• The distal extent of the tumor must be ≥ 12 cm from the anal verge on endoscopy or surgical examination 
• Must have ≥ 8 lymph nodes evaluated and reported
• Patient must have paraffin-embedded tumor specimen available for evaluation of molecular markers, must be submitted by day 50 post surgery
• Patient must be > 18 years old; ECOG PS 0-2
• No h/o isolated, distant or non-contiguous intra-abdominal metastases
• No h/o previous systemic or radiation therapy initiated for this malignancy

Primary Site / Sponsor

CALGB

C80405

For patient with Untreated locally advanced or metastatic colon or rectal cancer

Medical Oncology

Protocol Description

A Phase III Trial of Irinotecan/5-FU/Leucovorin or Oxaliplatin/ 5-FU/Leucovorin with Bevacizumab, or Cetuximab (C225), for Patients with Untreated Metastatic Adenocarcinoma of the Colon or Rectum

Eligibility

• Patient must have histologically or cytologically confirmed locally advdnced or metastatic adenocarcinoma of the colon or rectum that has not been resected
• Patient may have a h/o colorectal cancer treated by surgical resection and now have evidence of metastatic cancer
• Patient must have wildtype K-ras gene as determined by the SWOG Solid Tumor Repository
• No prior exposure to agents that target VGEF or EGF receptors, no prior exposure to bevacizumab or Cetuximab
• Patient may not have received any prior system treatment for advanced or metastatic disease
• No prior RT to greater than 25% of bone marrow
• No major surgery <4 weeks prior to randomization
• Patient with Gilbert’s Syndrome or known to be homozygous for UGTIAI*28 allele cannot be treated with FOLRIRI

Primary Site / Sponsor

Prostate

RTOG 0232

Radiation Oncology

Protocol Description

A Phase III Study Comparing Combined External Beam Radiation and Transperineal interstitial permanent Brachytherapy with Bradytherapy Alone for Selected Patients with Intermediate Risk Prostatic Carcinoma

Eligibility

• Stage T1c – T2b
• Zubrod Performance 0-1
• Prostate volume by TRUS ≤ 60cc
• Combined Gleason score 7 if PSA <10, combine Gleason score <7 if PSA 10 – 20
• PSA must be ≤ 20ng/mL, before hormone therapy, if given (if Gleason score 2-6, then PSA must be ≥10ng/mL)
• No prior chemo or pelvic radiation; no prior TURP, Cryosurgery, TUNA, TUMT, radical surgery for prostate cancer
• No distant metastases, no clinical or pathologically involved lymph nodes
• No previous hormonal therapy beginning < 2 months or > 6 months prior to registration
• No significant obstructive symptoms; AUA score must be ≤ 15 (alpha blockers allowed)
• No hip prosthesis
• No major medical or psychiatric illness

Primary Site / Sponsor

Advanced  NSCLC

CIRB
SWOG S-0819

Medical Oncology

Protocol Description

A Randomized, Phase III Study Comparing Carboplatin/ Paclitaxel or Carboplatin/Paclitaxel/Bevacizumab with or Without Concurrent Cetuximab in Patient with Advanced Non-Small Cell Lung Cancer

Eligibility

• Must have histologically or cytologically proven newly diagnosed Stage IV, primary NSCLC
• Treatment of brain mets must be stable off corticosteroids of minimum of 2 months
• Patient may have measurable or non-measurable disease documented on CT or MRI.  The CT from a combine PET/CT may be used to document only non-measurable disease unless it is of diagnostic quality
• Patients must agree to submission of specimen for EGFR FISH testing and other translational medicine studies
• No previous treatments with cetuximab, gefitinib, erlotinib or other investigational agents that target the EGFR pathway. No prior VEGF-related agents or prior chimerized or murine monoclonal antibody therapy or have documented presence of human anti-mouse antibodies (HAMA)
• Patient must have adequate renal, liver function and ANC ≥ 15000/mcl and Hb ≥9 mg/dl
• Patient must have a Zubrod Perfermance Status of 0-1

Primary Site / Sponsor

CIRB
RTOG 0617

Radiation Oncology/ Medical Oncology

Protocol Description

Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High Dose (74 Gy) Conformal Radiotherapy With Concurrent and Consolidation Carboplatin/Paclitaxel +/- Cetuximab (IND #103444)  In Patients with Stage IIIA/IIIB Non-Small Cell Lung Cancer

Eligibility

• Histologically or cytological documentation of NSCLC within 12 week prior to registration
• Patient must be newly diagnosed unresectable
• Patient must be stage IIIA/ IIIB with no evidence of distant  mets
• If the patient had exploratory thoracotomy, must be done at least 3 weeks prior to registration
• Zubrod Performance Status 0-1
• Prior to registration must have CT/MRI of lung and upper abdomen through adrenal glands and MRI/CT of brain with contrast (MRI without contrast only permitted if patient has contrast
• Women of childbearing potential, must have a negative urine or serum pregnancy test within 72 hours prior to the start of treatment
• Women of childbearing potential or  sexually active men, must be willing/able to use medically acceptable forms of contraception
• Patients with supraclavicular or contralateral hilar adenopathy are ineligible

Primary Site / Sponsor

DLBCL or Follicular NHL

U4391g
Genentech

Protocol Description

A Phase III Multi-Center Open-Label Study of Rituximab Faster Infusion Time in Patients with Previously Untreated Diffuse Large B-Cell or Follicular Non-Hodgkin’s Lymphoma

Eligibility

• Previously untreated DLBCL and scheduled to get Rituximab 375mg/m2 + CHOP  OR
• Previously untreated follicular NHL and scheduled to get Rituximab 375mg/m2 + CVP
• ECOG PS 0-2
• Planned treatment DOES NOT include the use of DECADRON
• No significant h/o cardiovascular disease, ventricular arrhythmias or peripheral vascular disease

Primary Site / Sponsor

Supportive Study

Cancer and Leukemia
Group B

CALGB 70604

Protocol Description

A Randomized Phase III Study of Standard Dosing versus Longer Dosing Interval of Zoledronic Acid in Metastatic Cancer

Eligibility

• Histologically documentation of prostate adenocarcinoma, breast adenocarcinoma or multiple myeloma
• At least one bone metastasis by radiographic imaging
• No prior IV bisphosphonate treatment
• No prior radiopharmaceuticals
• ≥ 4 weeks since completion of prior radiation therapy
• Prior non-investigational adjuvant and metastatic chemotherapy, biologic therapy and endocrine therapy is allowed
• No current treatment with investigational agent (s)
• Patient with brain metastases are not eligible
• Not pregnant and not nursing

Primary Site / Sponsor

Supportive Study

SWOG
S0702

Protocol Description

A Prospective Observational Multicenter Cohort  Study To Assess The Incidence Of Osteonecrosis Of The Jaw (ONJ) In Cancer Patients With Bone Metastases Starting Zoledronic Acid Treatment

Eligibility

• Bone metastasis from multiple myeloma, solid tumor, or other malignancy where bisphosphonate is indicated
• Planned treatment with zoledronic acid
• ≤3 doses IV ibandronate, pamidronate or zoledronic acid in the past 3 years for osteopenia or osteoporosis
• ≤ 90 days IV ibandronate, pamidronate, or zoledronic acid for metastatic bone disease
• Zubroid performance status of  0-3
• Willing to provide information regarding smoking history, alcohol consumption , pain assessments
• Willing to undergo dental assessments every six months
• Willing to provide access to prior or future dental information
• Participation on other therapeutic or non-therapeutic trials okay
• No h/o osteonecrosis of the jaw
• No previous cancer treatment with radiation therapy to oral maxillofacial region for therapeutic intent