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Ro 31-7453 in Treating Patients With Locally Advanced or Metastatic Solid Tumor

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ClinicalTrials.gov Identifier: NCT00003755
Recruitment Status : Completed
First Posted : June 3, 2004
Last Update Posted : June 25, 2013
Information provided by:

Study Description
Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase I trial to study the effectiveness of Ro 31-7453 in treating patients who have locally advanced or metastatic solid tumor.

Condition or disease Intervention/treatment Phase
Unspecified Adult Solid Tumor, Protocol Specific Drug: MKC-1 Phase 1

Detailed Description:

OBJECTIVES: I. Determine the maximum tolerated dose of Ro 31-7453 in patients with solid tumors. II. Determine the toxicity of Ro 31-7453 in this patient population. III. Evaluate the pharmacokinetics and major metabolites of Ro 31-7453 in these patients. IV. Assess any antitumor activity of Ro 31-7453 in these patients.

OUTLINE: This is a dose escalation study. Patients are treated on one of two treatment arms. In the first stage, cohorts of 1 patient each on arm I receive oral Ro 31-7453 twice daily on days 1-4, and cohorts of 1 patient each on arm II receive oral Ro 31-7453 once daily on days 1-4 at two dose levels higher than for arm I. Dose escalation ceases for each arm with the first instance of dose limiting toxicity (DLT). Two additional patients are entered at the stopping dose for each arm. If no further DLT occurs, the study proceeds to the second stage. In the second stage, dose escalation continues in increments of one dose level for each dosing schedule (arms I and II). Cohorts of 3-6 patients receive escalating doses of Ro 31-7453 in the absence of DLT. If 2 of 6 patients experience DLT at a dose level, escalation ceases and the maximum tolerated dose is defined as the previous dose level. Treatment continues every 3 weeks for 8 courses in the absence of disease progression or unacceptable toxicity. After completion of the 8 courses, patients may continue treatment until disease progression at the discretion of the investigator and the study sponsor. Patients are followed at 4 weeks.

PROJECTED ACCRUAL: A maximum of 40 patients will be accrued for this study over 18 months.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Primary Purpose: Treatment
Official Title: Phase I Study of R031-7453, a Novell Cell Cycle Inhibitor, Administered as Escalating Oral Doses in Adults With Solid Tumors: 4-Day Schedule
Study Start Date : October 1998
Primary Completion Date : August 2001
Study Completion Date : August 2001
Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed locally advanced and/or metastatic solid tumors for which no standard therapy is available No known CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: At least 12 weeks Hematopoietic: Hemoglobin at least 9 g/dL WBC at least 3,000/mm3 Granulocyte count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT and/or AST no greater than 2.5 times ULN (no greater than 4.0 times ULN if liver or bone metastasis present) Alkaline phosphatase no greater than 2.5 times ULN (no greater than 4.0 times ULN if liver or bone metastasis present) Renal: Creatinine no greater than 1.5 times ULN OR Creatinine clearance at least 60 mL/min Other: Not pregnant or nursing Fertile patients must use effective contraception No history of other serious medical conditions

PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior biologic therapy Chemotherapy: At least 4 weeks since prior chemotherapy (6 weeks since mitomycin or nitrosoureas) Endocrine therapy: At least 4 weeks since prior hormonal therapy Concurrent antiandrogen therapy allowed Radiotherapy: At least 4 weeks since prior extended field radiotherapy Surgery: Not specified

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00003755

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Steven Soignet, MD Memorial Sloan Kettering Cancer Center
More Information

ClinicalTrials.gov Identifier: NCT00003755     History of Changes
Other Study ID Numbers: 98-099
CDR0000066879 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: June 3, 2004    Key Record Dates
Last Update Posted: June 25, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
unspecified adult solid tumor, protocol specific