Phase I Study of Daily RAD001 in Combination With Mitomycin C in Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction (S387)

August 2, 2012 updated by: Krankenhaus Nordwest

Phase I Study of Daily RAD001 Administered Orally in Combination With Mitomycin C, Administered Every Three Weeks to Patients With Advanced Gastric Cancer or Cancer of the Esophagogastric Junction

Patients with advanced gastric cancer are treated with a combination of RAD001 (everolimus) and Mitomycin C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this monocenter, single-arm, phase I trial is to determine the maximum-tolerated-dose, dose-limiting toxicity (DLT) and preliminary efficacy and safety of RAD001 in combination with Mitomycin C in patients with advanced gastric cancer.

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Frankfurt, Germany, 60488
        • Krankenhaus Nordwest

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1 prior platin containing chemotherapy in the palliativ setting or progressive disease under adjuvant or neoadjuvant therapy within 6 months of treatment start date.
  • Histological evidence of advanced or metastatic gastric cancer or cancer of the esophageal junction.
  • At baseline CT or MRI scan must demonstrate measurable disease by RECIST criteria, i.e., the presence of at least one measurable lesion. Measurable disease lesions must be accurately measured in at least one dimension with longest diameter > 20 mm using conventional techniques or > 10 mm with spiral CT scan (with minimum lesion size no less than double the slice thickness).
  • At least one measurable lesion outside of the field of any prior radiation therapy (according to RECIST criteria). Prior radiotherapy to a single index lesion is not allowed.
  • Adult male or female patients (≥18 years of age).
  • Patients must have disease not amenable to surgery, radiation, or combined modality therapy with curative intent.
  • ECOG 0 or 1
  • Life expectance >4 months
  • Adequate bone marrow function, renal function, liver function
  • Women using an acceptable form of contraception prior to receiving RAD001 or women who meet the protocol definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy.
  • Fully recovered from any previous surgery, prior chemotherapy or radiation therapy (at least 4 weeks since major surgery or prior myelosuppressive chemotherapy). With the exception of alopecia, patients must have resolution of all acute toxic effects of any prior surgery, radiotherapy, or chemotherapy to NCI CTC (Version 2.0) grade <=1. Patients with rapidly progressive tumors (upon the decision of the investigator) can be treated <4 weeks since last chemotherapy, if they fully recovered from all side effects.
  • Signed informed consent

Exclusion Criteria:

  • Anticancer therapy within 3 weeks of enrollment including chemotherapy, hormonal therapy, immunotherapy, or radiotherapy. Patients with rapidly progressive tumors (upon the decision of the investigator) can be treated <4 weeks since last chemotherapy, if they fully recovered from all side effects.
  • Prior therapy with RAD001 (everolimus) or other rapamycins (sirolimus, temsirolimus).
  • Patients treated with Mitomycin C
  • No neurotoxicity >= grade 2 CTC
  • No gastric or intestinal obstruction
  • Patients taking drugs known to inhibit or induce isoenzyme CYP3A
  • Patients with any concurrent major medical condition liable to compromise the patient's participation in the study (e.g known HIV infection, uncontrolled diabetes, serious cardiac dysrhythmia or condition, New York Heart Association classification of III or IV, congestive cardiac failure, myocardial infarction within 6 months, unstable angina, chronic or acute renal or liver disease, uncontrolled serious infections including abscess or fistulae, etc.)
  • Patients with a history of another malignancy prior to study entry, except curatively treated non-melanotic skin cancer or carcinoma in-situ cervical cancer unless in complete remission or no evidence of disease and off all therapy for that disease for a minimum of 5 years
  • No symptomatic brain metastasis.
  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
  • Female patients who are pregnant or breast feeding
  • History of hypersensitivity to any of the study drugs or to drugs with similar chemical structures
  • History of malignancy of any organ system, treated or untreated, within the past 5 years whether or not there is evidence of local recurrence or metastases, with the exception of localized basal cell carcinoma of the skin

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RAD-MitC
RAD001 orally daily 5mg or 7.5mg or 10mg Mitomycin C 5mg/m2 every 3 weeks
Drug: RAD001 and MitomycinC

RAD001 tablets daily, 5mg, 7.5 mg or 10 mg (3 cohorts)

Mitomycin C 5 mg/m2 i.v. every 3 weeks

Other Names:
  • RAD001 (everolimus)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
maximum tolerated-dose (MTD) of RAD001 in combination with Mitomycin C
Time Frame: every week
every week

Secondary Outcome Measures

Outcome Measure
Time Frame
preliminary efficacy of RAD001 in refractory gastric cancer. Efficacy is defined as complete response or partial response at 12 weeks based on RECIST-criteria
Time Frame: every 6 weeks
every 6 weeks
progression-free survival (PFS)
Time Frame: every 6 weeks
every 6 weeks
overall survival (OS)
Time Frame: every three months
every three months
safety and tolerability of the combination of RAD001 and Mitomycin C as assessed by frequency, severity, and duration of treatment-related adverse effects
Time Frame: every week
every week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Krankenhaus Nordwest

Investigators

  • Principal Investigator: Salah-Eddin Al-Batran, MD, Krankenhaus Nordwest

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

August 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

January 5, 2010

First Submitted That Met QC Criteria

January 5, 2010

First Posted (Estimate)

January 6, 2010

Study Record Updates

Last Update Posted (Estimate)

August 3, 2012

Last Update Submitted That Met QC Criteria

August 2, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRAD001C24126

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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