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Solid Tumors

Prostate Cancer

1

Disease Status and/or Stage Androgen Independent Prostate Cancer
Protocol Title Phase I Open-Label Study to Determine the Maximum Tolerated Dose and to Evaluate the Safety Profile of Lenalidomide with every three week Docetaxel (Taxotere) in Subjects with Androgen Independent Prostate Cancer
PI Scott Tagawa , MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patients must have histologically confirmed prostate cancer and have measurable or evaluable androgen independent prostate cancer stages D1 or D2. Patients must have metastatic prostate cancer unresponsive or refractory to androgen blockade. Patients must be surgically or medically castrated and must not have received more than two chemotherapy regimens.
Treatment Overview For each participant, the study consists of two phases: Treatment Phase and the Extension Phase. In the treatment phase, patients meeting all inclusion/exclusion criteria will be enrolled in groups of 6 to receive lenalidomide by a single oral daily dose on Days 1-14 in combination with docetaxel administered IVPB over 60 minutes on Days 1 of each 21-day cycle. Patients will also take prednisone 5 mg BID daily. The study will follow a sequential dose escalation.

The Extension Phase consists of all cycles of treatment administered after the first 21 days of treatment. Subjects without clinical evidence of progressive disease at the end of the first cycle of therapy will be eligible for the extension phase. Study treatment is to continue until disease progression, unacceptable toxicity develops, or the subject chooses to discontinue study treatment.

2

Disease Status and/or Stage Prostate Cancer post Radical Prostatectomy
Protocol Title A Phase III trial of short term androgen deprivation with pelvic lymph node or prostate bed only radiotherapy (SPPORT) in prostate cancer patients with a rising PSA after radical prostatectomy
PI Scott Tagawa , MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patient must have pathologically confirmed prostate cancer, stage N0 or Nx. PSA = 0.2 and < 2.0 at least 6 weeks after prostatectomy and within 30 days of registration. Gleason score of 8 or less.
Treatment Overview

Radiotherapy will start within 6 weeks after registration in Arm 1 and two months after starting LHRH agonist treatment in Arms 2 and 3.

Arm 1: Prostate Bed Radiotherapy (PBRT) Alone: PBRT 64.8-70.2 Gy

Arm 2: Prostate Bed Radiotherapy + neoadjuvant and concurrent short term androgen deprivation (NC-STAD): PBRT 64.8-70.2 Gy + NC-STAD for 4-6 months, beginning 2 months before radiotherapy

Arm 3: Pelvic Lymph node radiotherapy (PLNRT) + Prostate bed radiotherapy + anti-androgen: PLNRT 45 Gy and PBRT to 64.8-70.2 Gy. NC-STAD for 4-6 months, beginning 2 months before radiotherapy

3

Disease Status and/or Stage Metastatic prostate cancer.
Protocol Title A phase I trial of docetaxel/prednisone plus fractionated 177Lu-J591 anti-prostate-specific membrane antigen monoclonal antibody in patients with metastatic, castrate-resistant prostate cancer
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 cancer, 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. Patients 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.

4

Disease Status and/or Stage Metastatic prostate cancer.
Protocol Title A Phase III, Randomized, Double-Blind, 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 Patients must have a histologic diagnosis of prostate adenocarcinoma and have progressive metastatic prostate cancer despite adequate medical or surgical castration therapy.
Treatment Overview

Patients will receive docetaxel, 75 mg/m2 every 21 days. In addition, patients will be assigned to one of five dose levels of 177Lu-DOTA-J591. Patients will receive two infusions of 177Lu-DOTA-J591 two weeks apart starting on 2-3 days prior to cycle 3 of docetaxel. Cycle 4 of docetaxel will be delayed until recovery from 177Lu-DOTA-J591-associated hematologic toxicity. Patients will be followed for toxicity and efficacy endpoints.

5

Disease Status and/or Stage Relapsed prostate cancer.
Protocol Title A Randomized Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591 (177Lu-J591) and ketoconazole in Patients with High-Risk Castrate Biochemically Relapsed Prostate Cancer After Local Therapy
PI Scott Tagawa, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patients must have histologically or cytologically confirmed adenocarcinoma of the prostate previously treated with surgery and/or radiotherapy and biochemical progression (rising PSA) after medical or surgical castration.
Treatment Overview

Participants will be randomized in a 2:1 fashion to receive ketoconazole with 70 mCi/m2 of 177Lu-J591 or trace-labeled 111In-J591. Patients will receive ketoconazole (400 mg po TID) plus hydrocortisone (20 mg am, 10 mg pm) for 4 weeks followed by a single infusion of 177Lu-J591 or trace-labeled 111In-J591, then continue ketoconazole / hydrocortisone until progression/toxicity. Patients will be followed for response, disease progression, and toxicity with the primary endpoint of time to radiographically apparent metastatic disease.

6

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 two 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, subjects will be randomized to the PHA-739358 selected schedule from Step 1 or a control treatment (mitoxantrone plus prednisone or an approved second 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.

7

Disease Status and/or Stage Untreated 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 Kristen Petrillo, RN
212-746-5430
Key Eligibility Progressive hormone-refractory metastatic prostate cancer based on progressive bidimensionally measurable disease (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 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.

8

Disease Status and/or Stage Metastatic, hormone-refractory prostate cancer
Protocol Title A Phase 2 Trial of 177Lu Radiolabeled Monoclonal Antibody HuJ591-GS (177Lu-J591) in Patients with Metastatic Androgen-Independent Prostate Cancer
PI David Nanus, MD
Contact Kristen Petrillo, RN
212-746-5430
Key Eligibility Patients must have metastatic, hormone-refractory prostate cancer with evidence of progressive disease. May have received prior chemotherapy. Limited prior radiation therapy to the skeleton. Adequate blood counts.
Treatment Overview Eligible patients will receive a single dose of 177Lu-J591 (65 or 70 mCi/m2) by IV infusion. One imaging study will be performed at 1 week post-treatment to confirm antibody targeting. Patients will be followed over the course of 12 weeks with close monitoring including physician visits and bloodwork.

9

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 Kristen Petrillo, 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.

10

Disease Statusand/orStage Metastatic Prostate Cancer
Protocol Title Radioimmunotherapy Phase I 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 LuJ591 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.

11

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.

12

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.

13

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 8, 2009
© Weill Medical College of Cornell University
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