MDACC Study Summary 2006-0806 (Archived)

Study Summary
No. 2006-0806:.......Colorectal......Cathy Eng......Gastrointestinal Medical Oncology

Study Summary Title



Study Summary Number:	2006-0806

Study Title:	A single arm, multicenter phase II study of RAD001 in patients with metastatic colorectal adenocarcinoma whose cancer has progressed despite prior therapy with an anti-EGFR antibody (if appropriate), bevacizumab, fluoropyrimidine, oxaliplatin, and irinotecan-based regimens (CRAD001C2241)

Physician

New Patient Referral



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

Dept:	Gastrointestinal Medical Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-792-2828 Contact us about clinical trials

General Information



Disease Group:	Colorectal	Supported By:	N/A

Phase of Study:	Phase II	Return Visit:	In cycles 1, 2 and 3, patients will return on day 14 for lab tests. Patients will return at the end of every cycle (28 day cycles)

Treatment Agents:	RAD001	Home Care:	Patients will not require homecare while participating in this study.

Treatment Loc:	Independent Multicenter Arrangements

Estimated Length of Stay in Houston:	This protocol does not require patients to be hospitalized


Description/ Intervention:	The goal of this clinical research study is to learn if RAD001 can slow the progression of colorectal cancer. The safety of RAD001 will also be studied.

Study Objectives / Outcomes

Primary objective
To assess disease control rate (DCR) and then objective response rate (ORR) as a measure
of the anti-tumor activity of two different regimens of RAD001.

Secondary objectives
1) To assess DCR and ORR as a measure of the antitumor activity of two different regimens of RAD001 according to phosphoinositide 3-kinase (PI 3-kinase) mutational status and phosphatase and tensin homolog (PTEN) (protein) expression.
2) To assess progression-free survival and overall survival of two different regimens of RAD001, and according to PI 3-kinase mutational status and PTEN (protein) expression.
3) To describe the safety profile of RAD001.
4) To explore other biomarkers that may be predictive of clinical benefit on RAD001.

Study Status Information



Study Activation / Registration Date:	07/02/2007

IRB Review and Approval Date:	07/02/2007

Study Type:	Phase Ii Or Phase I/Ii

Recruitment Status:	Terminated

Projected Accrual:	150

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) Age >/= 18 years old.

2) Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from the original resection of primary tumor.

3) Patients must have obtainable tumor tissue for biomarker analysis; only the original surgical resection is acceptable. Tumor tissue must be identified and reviewed to make certain that there is adequate tumor tissue available for biomarker evaluations, but actual procurement is not mandatory prior to study entry.

4) Patients with radiologically documented progressive disease by RECIST criteria during prior treatment or within 6 months of their most recent dose of chemotherapeutic regimens containing a fluoropyrimidine or oxaliplatin or irinotecan or targeted agent. Patients must have previously received anti-EGFR antibody (if appropriate, cetuximab or panitumumab), bevacizumab, fluoropyrimidine, oxaliplatin and irinotecan-based treatments. Patients with EGFR-negative tumors do not need to have previously received anti-EGFR antibody therapy.

5) Patients with at least one measurable lesion(s) by the RECIST criteria as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI), or physical examination.

6) Adequate bone marrow function as shown by: ANC >/= 1.5 x 10^9/L, Platelets >/= 100 x 10^9/L, Hb >9 g/dL.

7) Adequate liver function: serum bilirubin </= 1.5 x ULN, ALT and AST </= 2.5x ULN; patients with known liver metastases, AST and ALT </= 5x ULN.

8) Adequate renal function: serum creatinine </= 2 x ULN or 24-hour creatinine clearance >/= 50cc/24 hour.

9) Patients with a life expectancy >/= 3 months.

10) Patients with a WHO performance status of 0, 1, or 2.

11) Women of childbearing potential must have had a negative serum pregnancy test 72 hours prior to the administration of the first study treatment.

12) Patients who give a written informed consent obtained according to local guidelines.

Exclusion Criteria:

1) Patients currently receiving anti-cancer agents or who have received these within 4 weeks prior to study entry.

2) Patients who have previously received RAD001.

3) Patients with a known hypersensitivity to RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus) or to its excipients.

4) Chronic treatment with steroids or another immunosuppressive agent.

5) Patients with untreated central nervous system (CNS) metastases or neurologically unstable CNS metastases.

6) A known history of HIV seropositivity.

7) Patients with an active, bleeding diathesis. Patients may use enoxaparin.

8) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: unstable angina pectoris, symptomatic congestive heart failure, myocardial infarction </= 6 months prior to first study treatment, serious uncontrolled cardiac arrhythmia; severely impaired lung function; uncontrolled diabetes as defined by fasting serum glucose >1.5x ULN; any active (acute or chronic) or uncontrolled infection/ disorders.

9) Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation in the study such as: nonmalignant medical illnesses that are uncontrolled or whose control may be jeopardized by the treatment with the study therapy; liver disease such as cirrhosis, chronic active hepatitis or chronic persistent hepatitis

10) Patients who have a history of another primary malignancy </= 3 years, with the exceptions of non-melanoma skin cancer, and carcinoma in situ of uterine cervix.

11) Female patients who are pregnant or breast feeding, or adults of reproductive potential who are not using effective birth control methods. If barrier contraceptives are being used, these must be continued throughout the trial by both sexes. Oral contraceptives are not acceptable.

12) Patients who are using other investigational agents or who had received investigational drugs </= 4 weeks prior to first study treatment.

13) Patients unwilling to or unable to comply with the protocol.

Links

Registration Number: NCT00419159
Study Information on Clinical Trials Registry (clinicaltrials.gov)