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Solid Tumors

Colon/Rectal Cancer

1

Disease Status and/or Stage Stage II or III Rectal Cancer
Protocol Title E5204: Intergroup Randomized Phase III Study of Prospective Oxaliplatin, 5-Fluorouracil and Leucovorin vs Oxaliplatin, 5-Flourouracil, Leucovorin and Bevacizumab for Patients with Stage II or III Rectal Cancer Receiving Pre-Operative Chemoradiation
PI Allyson Ocean, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

Patients must have histologically-proven adenocarcinoma of the rectum with no distant metastases. Patients must have received a minimum radiation dose of 40Gy and not more than 54 Gy.

If patients did not participate in NSABP R-04, they must have received one of the treatments listed:
XRT + continuous infusion 5-FU
XRT + 5-FU +/- LV
XRT + capecitabine
XRT + 5-FU + Oxaliplatin
XRT + Capecitabine + Oxaliplatin

Treatment Overview Patients are randomized to receive oxaliplatin/leucovorin/5-FU or oxaliplatin/leucovorin/5-FU/bevacizumab

2

Disease Status and/or Stage Stage II adenocarcinoma of the colon
Protocol Title A Randomized Phase III Study Comparing 5-FU, Leucovorin andOxaliplatin 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
PI Allyson Ocean, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

Patients are eligible if they have a diagnosis of Stage II adenocarcinoma of the colon where the distal extent of the tumor is greater than or equal to 12 cm from the anal verge on endoscopy. Patients must have paraffin-embedded tumor specimen available for evaluation and no secondary malignancies.

Treatment Overview

Patients are randomized to one of two Arms:

Arm A: Patients receive oxaliplatin, leucovorin, 5-FU as an IV infusion

Arm B: Patients receive Bevacizumab, Oxaliplatin, Leucovorin and 5-FU as an IV infusion.

One cycle is two treatment days every 2 weeks.

3

Disease Status and/or Stage Metastatic Bone Tumors
Protocol Title A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain in Subjects who are Not Candidates for Radiation Therapy
PI Robert Min, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility All subjects must have been treated with at least one standard therapy (systemic therapy or local irradiation therapy) for metastatic cancer to the bone and must have failed adequate pain control with such therapy.
Treatment Overview Patients will metastatic cancer to the bone who have failed adequate pain control with other standard therapy will be treated with the MRgFUS procedure and followed over a three-month post-therapy period to determine the safety and effectiveness of the ExAblate procedure for palliation of pain.

Patients will be randomized onto one of two arms.
Arm A: ExAblate procedure to the most painful target lesion.
Arm B: Placebo ExAblate treatment.

4

Disease Status and/or Stage Any Stage of Cancer
Protocol Title Tinzaparin for Primary Treatment and Extended Secondary Prophylaxis of Venous Thromboembolism (VTE) in Patients with Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility

VTE Treatment Group: Eligible subjects must be age 18 years or older, diagnosed with active cancer and have a documented first venous thromboembolic event. Subjects must be currently receiving any treatment for cancer. In addition, subjects must have a documented first venous thromboembolic event (VTE). Subjects must not be in need of long-term anticoagulant therapy or be undergoing high dose chemotherapy for peripheral blood stem cell or bone marrow transplantation, induction chemotherapy for acute leukemia or has other conditions associated with persistent thrombocytopenia of less than 100x109/L for a duration of at least four consecutive weeks.

Control Group Patients: Eligible control patients will be matched patients aged 18 years or older and diagnosed with active cancer meeting the same criteria as above but without thrombosis
Treatment Overview

All eligible subjects with VTE will receive tinzaparin 175 U/kg/day for at least 6 months with another 6 months at the investigator's discretion (up to one year study treatment). Plasma markers of hemostasis, fibrolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months after start of tinzaparin treatment (if subject agrees).

Patients with cancer but without blood clots (control group) will also be enrolled in this study but will not receive study drug. For these patients, information regarding overall heath and response to their cancer treatment will be monitored. Plasma markers of hemostasis, fibrinolysis, and angiogenesis will be measured at baseline and at 7 days, 1 month, and 6 months (if subject agrees)

 
Last updated: July 30, 2008
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