MDACC Study Summary 2005-0099 (Archived)

Study Summary
No. 2005-0099:.......Gastrointestinal; Genitourinary; Gynecology; Head And Neck; Sarcoma......Saroj Vadhan-Raj......Cytokines and Supportive Care

Study Summary Title



Study Summary Number:	2005-0099

Study Title:	Phase I/II Study of AMG 531 in Patients with Advanced Malignancy Receiving Treatment with Chemotherapy

Physician

New Patient Referral



Name:	Saroj Vadhan-Raj	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Cytokines and Supportive Care	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-7966 Contact us about clinical trials

General Information



Disease Group:	Gastrointestinal Genitourinary Gynecology Head And Neck Sarcoma	Supported By:	N/A

Phase of Study:	Phase I/Phase II	Return Visit:	Clinic visits prior to each cycle (approximately every 3 weeks).

Treatment Agents:	Adriamycin AMG 531 Carboplatin Ifosfamide	Home Care:	Routine labs, management of myelosuppression and supportive care.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this clinical research study is to find the highest safe dose of AMG 531 that will decrease the risk and severity of thrombocytopenia (low platelet counts) in patients who have received chemotherapy. Researchers will also look at the safety and effectiveness of AMG 531 (Romiplostim).

Study Objectives / Outcomes

Primary
1. To determine the clinical safety and tolerability of AMG 531 administered following chemotherapy in patients with advanced malignancy
2. To determine an optimal biologic dose (OBD) of AMG 531 administered in patients receiving chemotherapy known to cause severe thrombocytopenia
3. To evaluate the effects of AMG 531 on the degree and duration of thrombocytopenia and platelet recovery following chemotherapy

Secondary
1. To evaluate limited pharmacokinetics of AMG 531 administered by S.C. route post-chemotherapy

Study Status Information



Study Activation / Registration Date:	08/04/2005

IRB Review and Approval Date:	03/16/2005

Study Type:	Therapeutic

Recruitment Status:	Terminated

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Patients with a diagnosis of solid tumors who are at high risk for chemotherapy-induced severe thrombocytopenia related to the following regimens: (a) Carboplatin (AUC=11); (b) AI regimen (adriamycin 75-90mg/m2, Ifosfamide 10gm/m2); (c) High dose Ifosfamide (14gm/m2)

2) Age >/= 18 years.

3) Adequate hematologic (ANC >/= 1500/mm^3, platelet count >/= 100 x 10^9/L and Hgb >/= 8 gm/dL), renal (serum creatinine </= 2.0 mg/dL), and hepatic functions (total bilirubin </= 2 times, SGPT or SGOT </= 3 times the upper limit of the respective normal range).

4) Karnofsky Performance Status >/= 80

5) Signed informed consent form

6) Patients with childbearing potential (defined as not post-menopausal for 12 months or no previous surgical sterilization) must have a negative pregnancy test and use adequate birth control. [i.e. oral contraceptives, spermicide with either a condom, diaphragm or cervical cap, use of an intrauterine device (IUD), or abstinence].

Exclusion Criteria:

1) Patients with rapidly progressive disease (such as patients with rapidly accumulating ascites or pleural effusion).

2) Patients with hematologic malignancies.

3) Pregnant or lactating women.

4) History of CNS metastasis.

5) Patients with significant cardiac disease (NYHA Class III or IV), dysarrhythmia, or recent history of MI or ischemia, transient ischemic attack or CVA within the previous 6 months of study entry.

6) Patients with a history of thromboembolic events (history of DVT or pulmonary embolus).

7) Prior chemotherapy, immunotherapy, or experimental drug (not FDA-approved drug) within 3 weeks. Patients will be eligible if day 1 of chemotherapy was initiated 3 weeks prior to study entry if the patient has recovery of blood counts and from acute toxicity of chemotherapy as described in inclusion criteria # 3.

8) Use of nitrosourea (BCNU, CCNU) or mitomycin - C within 6 weeks of study entry.

9) Prior surgery or Radiation Therapy (RT) within 2 weeks of study entry.

10) Patients with history of prior whole pelvic radiation will be excluded unless there is no prior history of severe thrombocytopenia (i.e. platelet nadir <10,000/mm^3)

11) Patients with history of prior high dose chemotherapy with stem cell transplant or with history of prolonged thrombocytopenia (>/= 2 weeks).

12) History of any platelet disorders including ITP, TTP or bleeding disorders.

13) History of > 4 prior chemotherapy regimens (all platinum regimens will be counted as one regimen).

14) Patients with significant bowel dysfunction secondary to tumor (significant abdominal pain with severe constipation/diarrhea (>/= Grade 3), significant difficulty maintaining oral nutrition).

15) Patients with pre-existing neuropathy > Grade 2.

Links

Registration Number: NCT00147225
Study Information on Clinical Trials Registry (clinicaltrials.gov)