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Solid Tumors

Breast cancer

1

Disease Status and/or Stage Metastatic or locally recurrent breast cancer
Protocol Title A Phase III Open Label, Randomized Parallel Two-Arm Multi Center Study of E7389 versus 'Treatment of Physician's Choice' in Patients with Locally Recurrent or Metastatic Breast Cancer, Previously treated with At Least Two and a Maximum of Five Prior Chemotherapy Regimens, Including an Anthracycline and Taxane
PI Linda Vahdat, MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Patients must have locally recurrent or metastatic breast cancer, and have received 2 to 5 prior chemotherapeutic regimens for breast cancer, at least two of which were for treatment of locally recurrent and/or metastatc disease. Regimens must have included an anthracycline and a taxane in any combination or order. Patients must have progressed within 6 months after their last chemotherapy.
Treatment Overview

Patients will be randomized to receive either E7389 by IV infusion at 1.4 mg/m2 on Days 1 and 8 every 21 days or "Treatment of Physician's Choice" (TPC), which can include anti-tumor treatment of the investigator's choice. If TPC therapy is assigned, dosing will be done according to accepted medical practice. Patients will continue on study until unacceptable toxicity, progression of disease, or until in the opinion of the investigator, discontinuation of therapy is in the pateint's best interest.

2

Disease Status and/or Stage Breast Cancer at moderate to high risk of recurrence (based on the number of involved lymph nodes); Stage 4 breast cancer without any evidence of disease.
Protocol Title Phase I Study of Dasatinib (BMS-354825) and Capecitabine for Advanced Breast Cancer
PI Linda Vahdat, MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Women with progressive advanced breast cancer, a histologic diagnosis of invasive breast cancer and prior treatment with a taxane and/or an anthracycline plus appropriate targeted (hormonal or Her2-directed) therapy. Patients must have recovered from
acute toxicities of prior therapy, have no elevation of serum creatinine, have good (0-1) performance status,
and have tumor tissue that is available for analysis. No prior capecitabine or Src-family kinase inhibitor,
and no more than 2 prior chemotherapy-containing regimens in the advanced setting is allowed.
Treatment Overview

Cohorts of 3-6 subjects will be treated with escalating doses of dasatinib and capecitabine to define a combination maximum tolerated dose. Only one of the two agents will be increased at each escalation. Both agents will be administered twice a day by mouth.

Subjects will remain on study until disease progression or at least 30 days after last dose of study drug, whichever is longer. No maximum duration of treatment is specified.

3

Disease Status and/or Stage Breast Cancer at moderate to high risk of recurrence (based on the number of involved lymph nodes); Stage 4 breast cancer without any evidence of disease.
Protocol Title A Phase II Study of Tetrathiomolydate (TM) in patients with breast cancer at moderate to high risk for recurrence
PI Linda Vahdat, MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Patients must have breast cancer and be at moderate to high risk of the tumor coming back. Patients must have completed standard treatment and be free of all detectable breast cancer metastases.
Treatment Overview

Patients will take TM pills starting at 4 times a day. The dose and schedule may change depending upon how long it takes to achieve the proper amount of copper depletion in the blood. Patients will be monitored for their copper level and CBC closely (weekly) for the first 4 weeks, then the evaluation of these parameters will stretch out to once every 4 weeks.
The maintenance phase will begin when the patient is on a stable TM dose (three times a day) and they have achieved the target copper level in the blood stream without side effects such as anemia. Patients will take TM for 2 years. If a patient relapses, they will be removed from study.

4

Disease Status and/or Stage Locally Advanced or Metastatic Breast Cancer
Protocol Title A Phase I/II Study of CR011-vcMMAE in Patients with Locally Advanced or metastatic Breast Cancer
PI Linda Vahdat, MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Female subjects with histologically or cytologically confirmed carcinoma of the breast. Prior treatment with a taxane and/or an anthracycline plus appropriate targeted (hormonal or Her2-directed) therapy.
Treatment Overview

Cohorts of 3-6 patients (depending on tolerability) will be administered CR011-vcMMAE intravenously (IV) once every 3 weeks until disease progression or evidence of significant treatment-related toxicities.

5

Disease Status and/or Stage Metastatic breast cancer
Protocol Title A Phase 2 Randomized, Multicenter Study of IMC-A12 as a Single Agent or in Combination with Antiestrogens in Postmenopausal Women with Hormone Receptor-Positive Advanced or Metastatic Breast Cancer After Progression on Antiestrogen Therapy
PI Ellen Chuang , MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Patients must have locally advanced or metastatic breast cancer, with life expectancy of at least 12 weeks. There is no limit on prior number of chemotherapy regimens received.
Treatment Overview

Patients will receive ixabepilone by IV infusion on Day 1 of each 21-day cycle at a dose of 40 mg/m2. Patients may receive ixabepilone on study until disease progression or unacceptable toxicity. Patients will receive extensive neurologic evaluations on study and will be assessed for side effects (by lab evaluations) and tumor response (after every other cycle) at regular intervals during the study. Additional procedures (blood drawns and punch biopsy of the skin of hands or feet) will be performed for correlative studies (research only).

6

Disease Status and/or Stage Metastatic breast cancer
Protocol Title Phase I/II Study of CR011-vcMMAE in Patients with Locally Advanced or Metastatic Breast Cancer
PI Linda Vahdat, MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Patients must have locally advanced or metastatic breast cancer, with life expectancy of at least 12 weeks. There is no limit on prior number of chemotherapy regimens received.
Treatment Overview

Patients will receive ixabepilone by IV infusion on Day 1 of each 21-day cycle at a dose of 40 mg/m2. Patients may receive ixabepilone on study until disease progression or unacceptable toxicity. Patients will receive extensive neurologic evaluations on study and will be assessed for side effects (by lab evaluations) and tumor response (after every other cycle) at regular intervals during the study. Additional procedures (blood drawns and punch biopsy of the skin of hands or feet) will be performed for correlative studies (research only).

7

Disease Status and/or Stage Any stage
Protocol Title A Randomized Placebo-Controlled Trial of Glutamine to Reduce the Signs and Symptoms of Peripheral Neuropathy in Breast Cancer Patients with a Mild Peripheral Neuropathy Receiving Paclitaxel Chemotherapy
PI Linda Vahdat, MD
Contact Person Marta Cobham, RN
212-821-0780
Key Eligiblity Patients with breast cancer who are receiving paclitaxel chemotherapy and have at least mild peripheral neuropathy (numbness, tingling, pain or weakness in the hands and feet).
Treatment Overview Patients will receive glutamine or placebo packets mixed in a beverage on the day of the paclitaxel infusion and will thereafter take 10 grams glutamine or placebo by mouth three times daily for 4 days.

8

Disease Status and/or Stage Early stage
Protocol Title A Phase III Trial Evaluating the Role of Ovarian Function Suppression and the Role of Exemestane as Adjuvant Therapies for Premenopausal Women with Endocrine Responsive Breast Cancer
PI Linda Vahdat, MD
Contact Marta Cobham, RN
212-821-0780
Key Eligibility Premenopausal women with hormone-receptor positive tumors who have received either no chemotherapy or remain premenopausal following completion of adjuvant and/or neoadjuvant chemotherapy.
Treatment Overview Arm A: Tamoxifen alone for 5 years

Arm B: Ovarian function suppression (OFS)* plus Tamoxifem for 5 years

Arm C: OFS* plus Exemetane for 5 years

*OFS options include ovarian irradiation OR bilateral oopherectomy OR Triptorelin for 5 years

9

Disease Status and/or Stage Stage I, II, or III breast cancer
Protocol Title Phase III Trial of Bisphosphonates as Adjuvant Therapy for Primary Breast Cancer
PI Linda Vahdat, MD
Contact Diana Donovan, NP
212-821-0780
Key Eligibility Patients must have primary invasive adenocarcinoma of the breast (Stage I, II, III) with no evidence of metastatic disease.· Patients must receive standard adjuvant therapy for their breast cancer.
Treatment Overview Patients will be randomized to receive one of three treatments:

Arm 1: zoledronic acid, given through a needle into a vein once a month for 6 months, then every 3 months for 2.5 years
Arm 2: clodronate, pill taken daily for 3 years
Arm 3: ibandronate, pill taken daily for 3 years

After three years, patients may receive non-protocol therapy at the physician’s discretion.

10

Disease Status and/or Stage Stages I-III
Protocol Title Phase III Trial of Continuous Schedule doxorubicin and cyclophosphamide (AC) + G-0CSF (G) versus every 2 Week Schedule AC, Followed by Paclitaxel (T) Given Either Every 2 Weeks or Weekly for 12 Weeks as Post-operative Adjuvant Therapy in Node-Positive or High-Risk Node Negative Breast Cancer
PI Linda Vahdat, MD
Contact Marta Cobham, RN
212-821-0780
Key Eligibility Patients must have histologically confirmed Stage I, II or III invasive breast carcinoma with known estrogen or progesterone receptor status. Patients with T4 tumors are not eligible.

No prior cytotoxic chemotherapy or radiation therapy for breast cancer or current malignancy
Treatment Overview Arm 1: AC + pegfilgrastim (PEG) x 6 cycles, followed by ever 2 week T+PEG x 6

Arm 2: AC + G x 15 weeks, followed by 2 week T+PEG x 6

Arm 3: AC +PEG x 6 cycles, followed by T x 12

Arm 4: AC+G x 15 weeks, followed by weekly T x 12

11

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.

12

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: March 20, 2009
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