NCT00005990

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of R115777 plus topotecan in treating patients who have advanced solid tumors.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 5, 2000

Completed
27 days until next milestone

Study Start

First participant enrolled

August 1, 2000

Completed
2.5 years until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Last Updated

November 9, 2012

Status Verified

January 1, 2006

Enrollment Period

6.1 years

First QC Date

July 5, 2000

Last Update Submit

November 8, 2012

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Interventions

tipifarnibDRUG
topotecan hydrochlorideDRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed advanced solid tumor not amenable to standard curative therapy PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * At least 6 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT no greater than 5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 5 times ULN * No significant hepatic dysfunction that would preclude study Renal: * Creatinine no greater than 1.5 mg/dL OR * Creatinine clearance at least 50 mL/min Cardiovascular: * No significant cardiovascular dysfunction that would preclude study Other: * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No malabsorption syndrome, partial or complete bowel obstruction, disease significantly affecting gastrointestinal function, or major resection of the stomach or proximal small bowel * At least 1 week since prior active infection requiring systemic medical therapy * No significant organ system dysfunction (neurologic, endocrine) that would preclude study * No dementia or altered mental status that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No more than 3 prior chemotherapy regimens * At least 4 weeks since prior chemotherapy and recovered Endocrine therapy: * Not specified Radiotherapy: * No more than 25% of bone marrow volume irradiated * No prior pelvic radiation * At least 4 weeks since prior radiotherapy and recovered Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

NYU Cancer Institute at New York University Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

tipifarnibTopotecan

Intervention Hierarchy (Ancestors)

CamptothecinAlkaloidsHeterocyclic Compounds

Study Officials

  • Howard S. Hochster, MD

    NYU Langone Health

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2000

First Posted

January 27, 2003

Study Start

August 1, 2000

Primary Completion

September 1, 2006

Last Updated

November 9, 2012

Record last verified: 2006-01

Locations

US(1)