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Solid Tumors

Prostate Cancer

1

Disease Status and/or Stage Metastatic prostate cancer.
Protocol Title Placebo-Controlled Study of Abiraterone Actetate (CB7630) Plus Prednisone in Patients with Metastatic Castration-Resistant Prostate Cancer (CRPC) who have Failed Docetaxel-Based Chemotherapy
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Eligible subjects must be medically or surgically castrated males age at least 18 years, with metastatic CRPC, and have failed docetaxel-based chemotherapy. Patients must have had one but not more than 2 cytoxic chemotherapy regimens for metastatic castration-resistant prostate cance, and at least one of those regimens must have contained docetaxel. If docetaxel-containing chemotherapy is used more than once, this well be considered as one regimen.
Treatment Overview

Eligible subjects will be randomized to receive abiraterone plus prednisone or placebo plus prednisone. Patients will take 4 tablets (abiraterone/placebo) orally once daily, in 28-day cycles. Total dose is 1000 mg/day. Patients will also take 5 mg prednisone twice daily.

Study treatment will remain blinded at time of disease progression. No crossover will be permitted between the 2 treatment groups. Patietns will return to clinic for cycle 1 day 15 visit to evaluate safety and dosing compliance (a count of study drug tablets). From cycle 2 to end of study, day 1 vists will occur every 28 days. Patients will have required tumor assessments at day 1 of cycle 4, 7 and 10 and every 3rd cycle beyond cycle 10. They may have additional imaging visits up to 8 days before cycles requiring images or at treatment discontinuation visit. During the follow-up period, patients may be contacted every 3 months for up to 5 years by phone interview.

2

Disease Status and/or Stage Metastatic hormone-refractory prostate cancer.
Protocol Title A Phase II Study of PHA-739358 in Patients with Metastatic Hormone Refractory Prostate Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patients must have histologically confirmed hormone-refractory metastatic prostate cancer that has progressed after first line docetaxel-based chemotherapy.
Treatment Overview

Eligible subjects will participate in one of 2 Steps of the study. Patients in Step 1 will be randomized to receive one of two PHA-739358 dose schedules (Arm A or Arm B). Arm A subjects will receive 330 mg/m2 by 6-hour IV infusion on Days 1, 8, and 15 in 28-day cycles. Arm B subjects will receive 500 mg/m2 as a 24-hour IV infusion on Days 1 and 15 in 28-day cycles.

If the study proceeds into Step 2, Step 2 subjects will be randomized to the PHA-739358 selected schedule from Step 1 or a control treatment (mitoxantrone plus prednisone or an approved 2nd line treatment).

All subjects will receive study treatment until disease progression, unacceptable toxicity, or withdrawal of consent. Serum PSA levels will be monitored every 4 weeks until confirmed PSA progression. Tumor imaging will occur every 8 weeks until documented tumor progression.

3

Disease Status and/or Stage Metastatic hormone-refractory prostate cancer.
Protocol Title A Phase I Study of a Chimeric Antibody Against Interleukin-6 (CNTO 328) Combined with Docetaxel in Subjects with Metastatic Hormone-Refractory Prostate Cancer
PI David Nanus, MD
Contact Stephanie Erichsen, RN
212-746-5430
Key Eligibility Progressive hormone-refractory metastatic prostate cancer based on progressive bidimensionally measurable disease (by x-ray, CT, and/or MRI) and serum PSA progression; progressive bone disease as evidenced by bone scan and serum PSA progression; and/or bidimensionally measurable disease (by x-ray, CT, and/or MRI) not progressing with serum PSA progression. No prior chemotherapy permitted.
Treatment Overview Patients may receive up to 14 cycles of study treatment, until evidence of disease progression or unacceptable toxicity.

Subjects responding to treatment with at least stable disease after 14 cycles will be able to receive 3 additional cycles of treatment.

The study consists of 4 phases: screening, 2 or 3-week run-in phase (patients will receive either docetaxel or CNTO 328), treatment Cycles 1 through 17, and follow-up. Patients are assigned to one of 4 dose cohorts

4

Disease Statusand/orStage Prostate cancer with bone metastases
Protocol Title A Randomized, Double-Blind, Placebo-Controlled, Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
PI David Nanus, MD
Contact Stephanie Erichsen, RN
212-746-5430
Key Eligibility No prior treatment w/a  bisphosphonate or radiopharmaceuticals; Histologic documentation of prostate adenocarcinoma w/at least one bone metastasis.
Treatment Overview Zoledronic Acid 4 mg IV over 15 minutes every 4 weeks or placebo IV every 4 weeks.

5

Disease Statusand/orStage Metastatic Prostate Cancer
Protocol Title Radioimmunotherapy Dose-Escalation Studies in Prostate Cancer using 177Lu-J591 Antibody: Dose Fractionation Regimen
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patients must have progressive, castrate metastatic prostate cancer as shown by presence of metastatic disease on imaging and at least one of the following
(1) progressive tumor lesions on CT or MRI;
(2) new osseus lesions on bone scan; and/or
(3) rising PSA.
Patients must not have had cytotoxic chemotherapy and/or radiation therapy within 4 weeks of study treatment.
Treatment Overview Patients will receive two doses of the study agent 177Lu-J591 mAb, 2 weeks apart. The dose of huJ591 MAb will remain fixed at a total dose of 20 mg/dose. The 177Lu dose will be escalated in cohorts at each dose level as specified in the protocol, and the amount of units in millicuries of radioactivity will depend upon patients' height and weight.

Patients will be followed for a minimum of 12 weeks after the 2nd dose of 177Lu J591 (total 14 weeks) or until toxicities resolve, disease progression or administration of alternative therapy for the patient's prostate cancer.

6

Disease Statusand/orStage Prostate Adenocarcinoma
Protocol Title CALGB 90203: A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Histological documentation of prostate adenocarcinome (clinical stage T1-T3a and no radiographic evidence of metastatic disease). No prior treatment for prostate cancer including prior surgery (excluding TURP), pelvic lymph node dissection, radiation therapy, or chemotherapy. Patients may have received up to 3 months of androgen deprivation therapy (LHRH agonists, antiandrogens, or both) prior to being enrolled on the study.
Treatment Overview Patients will be randomized to receive either 18-24 weeks of androgen deprivation therapy plus chemotherapy followed by radical prostatectomy OR immediate radical prostatectomy.

7

Disease Statusand/orStage Refractory Prostate Cancer
Protocol Title S0421: Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo for Patients with Advanced Hormone Refractory Prostate Cancer
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patients must have a histologic diagnosis of adenocarcinoma of the prostate which is measureable or non-measurable. Patients must have metastatic prostate cancer deemed to be unresponsive or refractory to hormone therapy.
Treatment Overview Patients will be randomized to: docetaxel and prednisone with atrasentan versus placebo, on a 21 day cycle. Prior to receiving docetaxel, patients will be given dexamethasone as directed by the study doctor. The study lasts for 12 cycles but patients may continue to take the investigational drug or placebo for up to 52 weeks or for as long as the therapy is beneficial.

8

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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