Radiation Therapy and Chemotherapy in Treating Patients With Locally Advanced Cervical Cancer

A PHASE I STUDY OF PELVIC RADIATION THERAPY WITH CONCOMITANT WEEKLY CISPLATIN AND TOPOTECAN CHEMOTHERAPY IN PATIENTS WITH CERVICAL CARCINOMA WITHOUT EXTRA-PELVIC METASTASIS

Sponsoren

Hauptsponsor: Gynecologic Oncology Group

Mitarbeiter: National Cancer Institute (NCI)

Quelle Gynecologic Oncology Group
Kurze Zusammenfassung

This phase I trial is studying the side effects and best way to give radiation therapy when given together with topotecan and cisplatin in treating patients with locally advanced cervical cancer. This trial is also studying the best dose of topotecan when given in this regimen. Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy, such as topotecan and cisplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Combining radiation therapy with chemotherapy may kill more tumor cells.

detaillierte Beschreibung

PRIMARY OBJECTIVES:

I. Determine the safety and tolerability of pelvic radiotherapy, cisplatin, and topotecan in patients with locally advanced cervical cancer.

II. Determine the maximum tolerated dose (MTD) of topotecan when administered in this regimen in this patient population.

SECONDARY OBJECTIVES:

I. Determine the site of recurrence (local vs distant) in patients treated with this regimen.

OUTLINE: This is a multicenter, dose-escalation study of topotecan.

Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of topotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 1 of 6 patients experiences dose-limiting toxicity. Once the MTD is determined, an additional cohort of 20 patients receives treatment as above at the MTD.

After completion of study treatment, patients are followed periodically for 5 years.

Gesamtstatus Completed
Anfangsdatum September 2007
Primäres Abschlussdatum January 2012
Phase Phase 1
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
Incidence of patients with acute toxicity assessed by Common Terminology Criteria for Adverse Events version 3.0 Up to 30 days after completion of radiation therapy
Incidence of patients with chronic toxicity assessed by Common Toxicity Criteria Radiation Therapy Oncology Group/European Organisation for Research and Treatment of Cancer (CTC RTOG/EORTC) Up to 5 years
Sekundäres Ergebnis
Messen Zeitfenster
Site of treatment failure Up to 5 years
Einschreibung 11
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: Topotecan Hydrochloride Liposomes

Beschreibung: Given IV

Armgruppenetikett: Treatment (topotecan hydrochloride, radiation, cisplatin)

Anderer Name: Brakiva

Interventionsart: Radiation

Interventionsname: 3-Dimensional Conformal Radiation Therapy

Armgruppenetikett: Treatment (topotecan hydrochloride, radiation, cisplatin)

Interventionsart: Drug

Interventionsname: Cisplatin

Beschreibung: Given IV

Armgruppenetikett: Treatment (topotecan hydrochloride, radiation, cisplatin)

Teilnahmeberechtigung

Kriterien:

Inclusion Criteria:

- Histologically confirmed primary invasive carcinoma of the uterine cervix

- Stages IB2, II, IIIB, and IVA disease

- Any cell type

- No known metastasis to scalene nodes or organs outside the radiation field

- No known intraperitoneal metastases

- No evidence of extrapelvic disease based on negative CT or PET scan

- Must enroll within 8 weeks of diagnosis

- Performance status - GOG 0-2

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- Creatinine normal

- Creatinine clearance > 50 mL/min

- Prior ureteral obstruction allowed provided stent or nephrostomy tube has been placed

- No renal abnormalities, such as pelvic kidney, horseshoe kidney, or prior renal transplantation that would require modification of radiation fields

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception

- No other malignancy within the past 5 years except nonmelanoma skin cancer

- No septicemia or severe infection

- No other medical or psychiatric condition that would preclude study compliance

- No prior chemotherapy for any prior malignancy

- No prior cytotoxic chemotherapy for this malignancy

- No prior radiotherapy for any prior malignancy

- No prior pelvic or abdominal radiotherapy for this malignancy

- No prior therapy for this malignancy

Geschlecht: Female

Mindestalter: N/A

Maximales Alter: N/A

Gesunde Freiwillige: No

Insgesamt offiziell
Nachname Rolle Zugehörigkeit
Peter Rose Principal Investigator Gynecologic Oncology Group
Ort
Einrichtung:
University of Chicago Comprehensive Cancer Center | Chicago, Illinois, 60637, United States
University of Iowa Hospitals and Clinics | Iowa City, Iowa, 52242, United States
University of Missouri - Ellis Fischel | Columbia, Missouri, 65212, United States
Cooper Hospital University Medical Center | Camden, New Jersey, 08103, United States
MetroHealth Medical Center | Cleveland, Ohio, 44109, United States
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio, 43210, United States
Riverside Methodist Hospital | Columbus, Ohio, 43214, United States
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma, 73104, United States
Cancer Care Associates-Midtown | Tulsa, Oklahoma, 74104, United States
Tulsa Cancer Institute | Tulsa, Oklahoma, 74146, United States
Standort Länder

United States

Überprüfungsdatum

December 2014

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Bedingung Durchsuchen
Anzahl der Waffen 1
Armgruppe

Etikette: Treatment (topotecan hydrochloride, radiation, cisplatin)

Art: Experimental

Beschreibung: Patients undergo radiotherapy 5 days a week for 6 weeks. Patients receive cisplatin IV and topotecan IV over 30 minutes once weekly for a total of 6 weeks in the absence of disease progression or unacceptable toxicity.

Studiendesign Info

Zuweisung: N/A

Interventionsmodell: Single Group Assignment

Hauptzweck: Treatment

Maskierung: None (Open Label)

Quelle: ClinicalTrials.gov