MDACC Study Summary 2006-0414 (Archived)

Study Summary
No. 2006-0414:.......Phase I Studies; Solid Tumors......George Blumenschein......Phase I Program

Study Summary Title



Study Summary Number:	2006-0414

Study Title:	Phase I Study of SU011248 in Combination with Paclitaxel/Carboplatin in Patients with Advanced Solid Malignancies

Physician

New Patient Referral



Name:	George Blumenschein	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Phase I Program	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-1930 Contact us about clinical trials

General Information



Disease Group:	Phase I Studies Solid Tumors	Supported By:	N/A

Phase of Study:	Phase I	Return Visit:	Schedule 2/1 Cycle: 1: D -7, -6, 1, 2, 8, 16 2: D 1, 2, 8, 14 3 & 4: D 1, 8, 14 Continuous Dose Schedule Cycle: 1: D 1, 2, 8, 15, 16 2: D 1, 2, 8, 15 3: D 1, 8, 15, 4: D 1, 8, 15, 21 Both schedules: end study, 28 days post-treatment, Day 8 opt. for cycles 2-4

Treatment Agents:	Carboplatin Paclitaxel SU011248	Home Care:	N/A

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to find the highest tolerable dose
of SU011248 (sunitinib malate) that can be given in combination with paclitaxel
and carboplatin. Researchers will study if it is tolerable when given in
combination with paclitaxel and carboplatin and what side effects may occur
from this drug combination. Pharmacokinetics (PK -- how the drug moves around
in the body) and the effects of sunitinib malate on the tumor will also be
studied.

Study Objectives / Outcomes

Primary Objective:

To assess the maximum tolerated dose (MTD) and overall safety of SU011248 when administered on Schedule 2/1 and also when dosed continuously in combination with paclitaxel/carboplatin in patients with advanced solid tumors for whom curative therapy is not available.

Secondary Objective:

To evaluate the plasma pharmacokinetics of carboplatin, paclitaxel, SU011248, and its active metabolite SU012662 when these drugs are co-administered.
To assess antitumor activity of SU011248, carboplatin and paclitaxel when co-administered to patients with measurable disease.

Study Status Information



Study Activation / Registration Date:	02/27/2007

IRB Review and Approval Date:	08/09/2006

Study Type:	Phase I

Recruitment Status:	Terminated

Projected Accrual:	72

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) Histologically or cytologically proven diagnosis of any advanced solid malignancy that is not amenable to treatment with curative intent.

2) Candidates for treatment with carboplatin and paclitaxel

3) Maximum of 2 prior chemotherapy regimens

4) Male or female, 18 years of age or older

5) ECOG performance status 0 or 1

6) Life expectancy of >/= 12 weeks

7) Resolution of all acute toxic effects of prior therapy or surgical procedure to grade </= 1 (except alopecia)

8) Adequate organ function as defined by the following criteria: Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) </= 2.5 x upper limit of normal (ULN), or AST and ALT </= 5 x ULN if liver function abnormalities are due to underlying malignancy; total serum bilirubin </= 1.5 x ULN; absolute neutrophil count (ANC) >/= 2000/microliter; platelets >/= 100,000/microliter; hemoglobin >/= 9.0 g/dL; serum creatinine within normal range.

9) Signed and dated informed consent document indicating that the patient (or legally acceptable representative) has been informed of all pertinent aspects of the trial prior to enrollment

10) Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

Exclusion Criteria:

1) Prior treatment with high-dose chemotherapy requiring stem cell rescue

2) Prior irradiation to > 25% of the bone marrow (whole pelvis = 25%)

3) Prior chemotherapy, radiation therapy, or surgery within 4 weeks prior to study entry except palliative radiotherapy to non-target, metastatic lesions (2 weeks)

4) Diagnosis of any second malignancy within the past 3 years (unless discussed and approved by the Medical Monitor), except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma that has been adequately treated with no evidence of recurrent disease for 12 months

5) NCI CTCAE grade >/= 2 neuropathy from any cause

6) Treatment with anticonvulsant agents within 2 weeks prior to study entry

7) Ongoing treatment with therapeutic doses of Coumadin (low dose Coumadin up to 2 mg PO daily for deep vein thrombosis prophylaxis is allowed)

8) Current treatment on another therapeutic clinical trial or receipt of another investigative treatment within 4 weeks of study entry

9) Current treatment with medications that are known potent CYP3A4 inducers or inhibitors

10) History of untreated brain metastases. Patients may be entered with a history of brain metastases treated >/= 6 weeks prior to enrollment with whole brain radiation if the effects of treatment have resolved. Patients with treated brain metastases must have a post-treatment brain MRI showing no further progression of prior lesions AND no new metastatic lesions. Patients will not be eligible if they have any ongoing symptoms from brain metastases.

11) Any of the following within the 12 months prior to starting study treatment: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, congestive heart failure, cerebrovascular accident including transient ischemic attack, or pulmonary embolus.

12) NCI CTCAE Grade 3 hemorrhage < 4 weeks of starting study treatment

13) Hypertension (> 140/90 mm Hg) that cannot be controlled with standard antihypertensive agents.

14) Ongoing cardac dysrhythmias of grade >/= 2, atrial fibrillation of any grade, or QTc interval >450 msec for males or > 470 msec for females

15) History of Grade 3 or 4 toxicity or severe hypersensitivity reaction associated with prior treatment with paclitaxel and/or carboplatin

16) Known human immunodeficiency virus (HIV) seropositivity

17) Pregnancy or breastfeeding. All female patients with reproductive potential must have a negative pregnancy test (serum or urine) within the 7 days prior to enrollment.

18) Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results, and in the judgment of the investigator would make the patient inappropriate for entry into this study.

19) Patients cannot be on medications that could increase the risk of Torsade de Pointes or that may prolong the QT interval.

Links

Registration Number: NCT00511849
Study Information on Clinical Trials Registry (clinicaltrials.gov)