CP4071 in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

Phase II Evaluation Of CP4071 In Previously Treated Advanced Sarcomas

Sponsoren

Hauptsponsor: Herbert Irving Comprehensive Cancer Center

Mitarbeiter: National Cancer Institute (NCI)

Quelle National Cancer Institute (NCI)
Kurze Zusammenfassung

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

PURPOSE: Phase II trial to study the effectiveness of CP4071 in treating patients who have locally advanced or metastatic soft tissue sarcoma.

detaillierte Beschreibung

OBJECTIVES:

- Determine the efficacy, in terms of response rate, of CP4071 in patients with previously treated, locally advanced or metastatic soft tissue sarcoma.

- Determine the clinical toxic effects of this drug in these patients.

OUTLINE: Patients receive oral CP4071 daily. Treatment continues in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 25 patients will be accrued for this study.

Gesamtstatus Unknown status
Anfangsdatum October 2000
Phase Phase 2
Studientyp Interventional
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: CP4071

Teilnahmeberechtigung

Kriterien:

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed soft tissue sarcoma

- Metastatic or locally advanced

- Failed at least 1 prior therapy

- Measurable disease outside prior irradiation field

- No CNS metastases

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- SWOG 0-2

Life expectancy:

- Not specified

Hematopoietic:

- Not specified

Hepatic:

- Bilirubin no greater than 2 times upper limit of normal (ULN)

Renal:

- Creatinine less than 1.5 times ULN

- Calcium less than ULN

- Potassium normal

Other:

- No other malignancy within the past 5 years except stage I or II cancer in complete remission, carcinoma in situ of the cervix, or basal cell or squamous cell skin cancer

- Not pregnant or nursing

- Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Prior biologic response modifier therapy allowed

Chemotherapy:

- No more than 3 prior chemotherapy regimens for advanced, recurrent, or metastatic disease

- No other concurrent chemotherapy

Endocrine therapy:

- No concurrent hormonal therapy for malignancy

Radiotherapy:

- See Disease Characteristics

- At least 3 weeks since prior radiotherapy and recovered

- No concurrent radiotherapy

Surgery:

- At least 4 weeks since prior surgery and recovered

Other:

- No other concurrent cardiac glycosides

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Robert N. Taub, MD, PhD Study Chair Herbert Irving Comprehensive Cancer Center
Ort
Einrichtung: Herbert Irving Comprehensive Cancer Center
Standort Länder

United States

Überprüfungsdatum

September 2002

Schlüsselwörter
Hat den Zugriff erweitert No
Bedingung Durchsuchen
Studiendesign Info

Hauptzweck: Treatment

Quelle: ClinicalTrials.gov