Combination Chemotherapy in Treating Patients With Ovarian Epithelial, Fallopian Tube, or Peritoneal Cancer

Sponsor

AGO Study Group (Other)

Overall Status

Completed

CT.gov ID

NCT00031954

Collaborator

(none)

105

Enrollment

Locations

5.8

Patients Per Site

Study Details

Study Description

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 II trial to study the effectiveness of combination chemotherapy in treating patients who have stage IC, stage IIB, stage III, or stage IV ovarian epithelial, fallopian tube, or peritoneal cancer that has not been previously treated.

Condition or Disease	Intervention/Treatment	Phase
Fallopian Tube Cancer Ovarian Cancer Primary Peritoneal Cavity Cancer	Drug: carboplatin Drug: gemcitabine hydrochloride Drug: paclitaxel	Phase 2

Detailed Description

OBJECTIVES:

Determine the tolerability and toxicity of paclitaxel, carboplatin, and gemcitabine in patients with previously untreated stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma.
Determine the response rate of patients treated with this regimen.
Determine the time to progression and overall survival of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1 and gemcitabine IV over 30-60 minutes on days 1 and 8. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed at 3 and 6 months.

PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.

Study Design

Study Type:

Interventional

Actual Enrollment :

105 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase II Study Of Paclitaxel, Carboplatin And Gemcitabine In Previously Untreated Patients With Epithelial Ovarian Carcinoma FIGO Stage IIB-IV

Study Start Date :

Aug 1, 2001

Actual Primary Completion Date :

Apr 1, 2004

Outcome Measures

Primary Outcome Measures

Evaluation of tolerability and toxicity of the combination therapy with paclitaxel, carboplatin and gemcitabine (P-C-G) in first line treatment of ovarian cancer patients. Evaluation of Drop-out rate due to toxicity [Based on decision level]
The decision level is reached, when the lower exact 95% confidence limit of the observed proportion is higher than the upper exact 95% confidence limit of the historical proportion, which corresponds to a power of 0.5 applying a significance level of 0.05

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Histologically confirmed stage IC-IV ovarian epithelial, fallopian tube, or peritoneal carcinoma
No tumors of low-malignant potential (borderline tumors)
No symptomatic brain metastases

PATIENT CHARACTERISTICS:

Age:

18 and over

Performance status:

ECOG 0-2 OR
Karnofsky 70-100%

Life expectancy:

At least 6 months

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,500/mm^3
Platelet count at least 100,000/mm^3
Hemoglobin greater than 10 g/dL

Hepatic:

Bilirubin no greater than 2 times upper limit of normal

Renal:

Glomerular filtration rate at least 60 mL/min

Cardiovascular:

No history of congestive heart failure (New York Heart Association class III or IV heart disease) even if medically controlled
No myocardial infarction within the past 6 months
No history of atrial or ventricular arrhythmias

Neurologic:

No history of seizure disorder
No history of CNS disorder
No pre-existing motor or sensory neuropathy or symptoms grade 2 or greater

Other:

No severe concurrent infection
No prior hypersensitivity reaction to products containing Cremophor EL or compounds chemically related to carboplatin, paclitaxel, or gemcitabine
No complete bowel obstruction
No other concurrent severe medical problems that would preclude study
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

No concurrent immunotherapy
No concurrent WBC transfusions

Chemotherapy:

No prior chemotherapy
No other concurrent chemotherapy

Endocrine therapy:

No concurrent hormonal therapy except replacement therapy or steroid antiemetics

Radiotherapy:

No prior radiotherapy
No concurrent radiotherapy

Surgery:

No more than 6 weeks since prior definitive surgery

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Universitaetsklinikum Charite	Berlin	Germany	D-10117
2	Zentralkrankenhaus	Bremen	Germany	D-28205
3	Medizinische Klinik I	Dresden	Germany	D-01307
4	Evangelisches Krankenhaus	Dusseldorf	Germany	DOH-4-0217
5	Staedtisches Krankenhaus FFM-Hoechst	Frankfurt Am Main	Germany	65929
6	Klinikum der J.W. Goethe Universitaet	Frankfurt	Germany	D-60590
7	Universitaetsklinik Goettingen	Gottingen	Germany	D-37075
8	Klinik Fuer Innere Medizin Hematology/Oncology, Ernst Moritz Armdt Universitaet	Greifswald	Germany	D-17487
9	Frauenklinik der MHH	Hannover	Germany	30659
10	Vincentius Krankenhaus	Karlsruhe	Germany	D-76137
11	Christian-Albrechts University of Kiel	Kiel	Germany	D-24105
12	Klinik der Otto-v.-Guericke-Universitat	Magdeburg	Germany	39108
13	Klinik und Poliklinik fuer Kinderheilkunde	Muenster	Germany	D-48129
14	Klinikum Grosshadern	Munich (Muenchen)	Germany	D-81377
15	Klinikum Rechts Der Isar/Technische Universitaet Muenchen	Munich (Muenchen)	Germany	D-81675
16	Universitaetsklinikum Tuebingen	Tuebingen	Germany	D-72076
17	Universitaet Ulm	Ulm	Germany	D-89075
18	Dr. Horst-Schmidt-Kliniken	Wiesbaden	Germany	D-65199