Paclitaxel Plus Topotecan in Treating Patients With Solid Tumors

NCT00002587 | Completed Phase 1

• 4 other identifiers: NCI-2012-02235NYU-9315NCI-T93-0115DCDR0000063738
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Phase I trial to study the effectiveness of paclitaxel plus topotecan in treating patients who have solid tumors. 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.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Study Arms (1)

Arm I

EXPERIMENTAL

Patients receive paclitaxel IV over 3 hours on day 1 followed 2-6 hours later by topotecan IV continuously on days 1-14. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of topotecan and paclitaxel until the maximum tolerated dose (MTD) of each drug is determined. The MTD is defined as the highest dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Drug: paclitaxel; Drug: topotecan hydrochloride

Interventions

paclitaxel DRUG

Arm I

topotecan hydrochloride DRUG

Arm I

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven solid tumor * Measurable or evaluable disease * Measurable disease defined as tumor outside prior radiotherapy fields and reproducibly measurable in 2 dimensions on physical exam, x-ray, CT, or MRI PATIENT CHARACTERISTICS: * Age: 18 and over * Performance status: 0 or 1 * Life expectancy: At least 12 weeks * WBC at least 4,000/mm3 * Platelet count at least 100,000/mm3 * Bilirubin no greater than 1.5 mg/dL * AST less than 3 times normal * Alkaline phosphatase less than 3 times normal * Creatinine no greater than 1.5 mg/dL * No poorly controlled angina * No history of congestive heart failure * No myocardial infarction within the past 6 months * Not pregnant or nursing PRIOR CONCURRENT THERAPY: * No concurrent prophylactic hematopoietic growth factors * No concurrent medications altering cardiac conduction

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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

NYU School of Medicine's Kaplan Comprehensive Cancer Center

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Paclitaxel; Topotecan

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Camptothecin; Alkaloids; Heterocyclic Compounds

Study Officials

• Howard S. Hochster, MD

  NYU Langone Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: May 11, 2004
• Study Start: September 1, 1994
• Primary Completion: December 1, 2000
• Study Completion: December 1, 2000
• Last Updated: June 3, 2013

Record last verified: 2001-04

Locations

US (1)