Know Cancer

or
forgot password

A Single Arm, Multicenter Phase II Study of Everolimus 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


Phase 2
18 Years
N/A
Not Enrolling
Both
Colorectal Cancer

Thank you

Trial Information

A Single Arm, Multicenter Phase II Study of Everolimus 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

Inclusion Criteria


Inclusion criteria:

- Age ≥ 18 years old.

- Patients with metastatic colorectal cancer (CRC).

- Patients must have sufficient and obtainable tumor tissue for biomarker analysis from
original surgical resection.

- Patients with documented disease progression within 6 months of their most recent
dose of chemotherapeutic regimens.

- Patients with at least one measurable lesion.

- Adequate bone marrow function.

- Adequate liver function.

- Adequate renal function.

- Patients with a life expectancy of > 3 months.

- Patients with a World Health Organization (WHO) performance status of 0, 1, or 2.

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

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

Exclusion criteria:

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

- Patients who have previously received RAD001.

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

- Chronic treatment with steroids or another immunosuppressive agent.

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

- HIV seropositivity.

- Patients with an active, bleeding diathesis. Patients may use enoxaparin.

- Patients who have any severe and/or uncontrolled medical conditions or other
conditions that could affect their participation in the study.

- 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.

- Female patients who are pregnant or breast feeding, or adults of reproductive
potential who are not using effective birth control methods.

- Patients who are using other investigational agents or who had received
investigational drugs ≤ 4 weeks prior to first study treatment.

- Patients unwilling to or unable to comply with the protocol.

Other protocol defined inclusion/exclusion criteria may apply

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Control Rate (DCR) and Objective Response Rate (ORR) According to the Response Evaluation Criteria in Solid Tumors (RECIST)

Outcome Description:

RECIST (Response Evaluation Criteria In Solid Tumors) is a set of published rules that define when cancer patients improve ("respond"), stay the same ("stable") or worsen ("progression") during treatments. Disease Control Rate (DCR) defined as the percentage of participants with Disease Control best overall response (complete response, partial response or stable disease)and Objective Response Rate (ORR) defined as the percentage of participants with best overall Objective Response (complete response or partial response).

Outcome Time Frame:

Imaging every 8 weeks

Safety Issue:

No

Principal Investigator

Novartis Pharmaceuticals

Investigator Role:

Study Director

Investigator Affiliation:

Novartis Pharmaceuticals

Authority:

United States: Food and Drug Administration

Study ID:

CRAD001C2241

NCT ID:

NCT00419159

Start Date:

December 2006

Completion Date:

March 2009

Related Keywords:

  • Colorectal Cancer
  • Colorectal cancer
  • metastatic colorectal adenocarcinoma
  • anti-EGFR antibody
  • Adenocarcinoma
  • Colorectal Neoplasms

Name

Location

Nevada Cancer InstituteLas Vegas, Nevada  89135