Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer - Full Text View

Sponsors and Collaborators:	Gynecologic Oncology Group National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00004221

Purpose

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and peripheral stem cell transplantation in treating patients who have undergone surgery for stage III ovarian cancer.

Condition	Intervention	Phase
Ovarian Cancer Peritoneal Cavity Cancer	Biological: filgrastim Drug: carboplatin Drug: cyclophosphamide Drug: paclitaxel Drug: topotecan hydrochloride Procedure: peripheral blood stem cell transplantation	Phase II

MedlinePlus related topics: Cancer Ovarian Cancer

Drug Information available for: Cyclophosphamide Paclitaxel Carboplatin Topotecan hydrochloride Filgrastim Topotecan

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment
Official Title:	A Phase II Trial Using Multiple Cycles of High Dose Sequential Carboplatin, Paclitaxel and Topotecan With Peripheral Blood Stem Cell (PBSC) Support as Initial Chemotherapy in Patients With Optimally Debulked Stage III Ovarian Carcinoma

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

November 1999

Detailed Description:

OBJECTIVES:

Determine the safety and feasibility of multiple courses of high dose carboplatin, paclitaxel, and topotecan as initial chemotherapy combined with autologous peripheral blood stem cell transplantation in patients with optimally debulked stage III ovarian or primary peritoneal carcinoma.
Determine the pathological complete response rate, disease free survival, and overall survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Mobilization and harvest: Within 8 weeks of surgical debulking, patients receive cyclophosphamide IV over 1 hour, followed 4 hours later by paclitaxel IV over 24 hours. Patients receive filgrastim (G-CSF) subcutaneously (SQ) daily beginning 24 hours after completion of paclitaxel infusion and continuing until blood counts recover and autologous peripheral blood stem cells (PBSC) are harvested and selected for CD34+ cells.
High dose chemotherapy and transplantation (3 weeks after PBSC harvest): Patients receive paclitaxel IV over 24 hours beginning on day 1, immediately followed by carboplatin IV over 2 hours, immediately followed by topotecan IV over 24 hours. Patients receive G-CSF SQ daily beginning 24 hours after completion of topotecan infusion and continuing until blood counts have recovered for 2 days. One quarter of the PBSC are reinfused beginning 2 days after completion of topotecan infusion. Treatment repeats every 4 weeks for 4 courses in the absence of disease progression or unacceptable toxicity.

Patients with radiographic and biochemical complete response undergo laparoscopy as second look surgery within 8 weeks of the last course of chemotherapy. If no evidence of disease is found during laparoscopy, then exploratory laparotomy must also be performed.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter or at time of recurrence until death.

PROJECTED ACCRUAL: A total of 20-41 patients will be accrued for this study within 2 years.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically proven optimally debulked stage III ovarian or primary peritoneal carcinoma
- Any of the following subtypes:
  - Serous adenocarcinoma
  - Mucinous adenocarcinoma
  - Clear cell carcinoma
  - Transitional cell carcinoma
  - Endometrioid adenocarcinoma
  - Undifferentiated adenocarcinoma
  - Mixed epithelial adenocarcinoma
  - Adenocarcinoma, not otherwise specified
No ovarian carcinoma of low malignant potential (borderline)
Concurrent superficial endometrial or cervical carcinoma allowed if ovarian carcinoma more life threatening or limiting
Must have undergone appropriate primary surgical staging and debulking for ovarian carcinoma and have less than 1 cm of residual disease
- No more than 8 weeks since prior surgical debulking
Must have Hickman catheter in place or be eligible for placement
No CNS involvement

PATIENT CHARACTERISTICS:

Age:

Over 18

Performance status:

GOG 0 or 1

Life expectancy:

Not specified

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 or SGPT no greater than 2 times upper limit of normal
No active hepatitis

Renal:

Creatinine no greater than 1.5 mg/dL OR
Creatinine clearance at least 60 mL/min
No renal failure
Curatively treated ureteral obstruction allowed if above creatinine measurements met

Cardiovascular:

No congestive heart failure
No myocardial infarction within the past 6 months
No significant arrhythmias requiring medication
No poorly controlled systolic or diastolic hypertension (diastolic blood pressure consistently greater than 100 mm Hg)

Pulmonary:

No significant nonneoplastic pulmonary disease

Other:

No other malignancy within the past 5 years except basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
HIV negative
No other severe medical or psychiatric illness including, but not limited to the following:
- Acute infection
- Active peptic ulcer disease
- Uncontrolled diabetes mellitus
- Prior hospitalization for psychiatric illness, including severe depression or psychosis
- Concurrent alcohol or drug abuse

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy for this malignancy

Endocrine therapy:

Not specified

Radiotherapy:

No radiotherapy to greater than 25% of bone marrow

Surgery:

See Disease Characteristics

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004221

Locations

United States, California
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868
United States, Illinois
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
United States, Iowa
Holden Comprehensive Cancer Center at The University of Iowa
Iowa City, Iowa, United States, 52242-1009
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper Hospital/University Medical Center
Camden, New Jersey, United States, 08103
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Barrett Cancer Center, The University Hospital
Cincinnati, Ohio, United States, 45267-0502
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Fox Chase Cancer Center
Philadelphia, Pennsylvania, United States, 19111
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109-1024

Sponsors and Collaborators

Gynecologic Oncology Group

National Cancer Institute (NCI)

Investigators

Study Chair:

Russell J. Schilder, MD

Fox Chase Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067462, GOG-9903
Study First Received:	January 28, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00004221 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage III ovarian epithelial cancer
ovarian undifferentiated adenocarcinoma
ovarian mixed epithelial carcinoma
ovarian serous cystadenocarcinoma

ovarian mucinous cystadenocarcinoma
ovarian endometrioid adenocarcinoma
ovarian clear cell cystadenocarcinoma
peritoneal cavity cancer

Study placed in the following topic categories:

Cystadenocarcinoma, Serous
Immunologic Factors
Gonadal Disorders
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Carcinoma, Endometrioid
Genital Diseases, Female
Peritoneal Diseases
Ovarian Cancer
Alkylating Agents
Endocrine Gland Neoplasms
Ovarian Neoplasms
Digestive System Neoplasms
Genital Neoplasms, Female

Endocrine System Diseases
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Ovarian Epithelial Cancer
Immunosuppressive Agents
Carcinoma
Digestive System Diseases
Paclitaxel
Tubulin Modulators
Gastrointestinal Neoplasms
Antineoplastic Agents, Alkylating
Peritoneal Neoplasms
Endocrinopathy
Antirheumatic Agents

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Gonadal Disorders
Physiological Effects of Drugs
Urogenital Neoplasms
Ovarian Diseases
Cyclophosphamide
Genital Diseases, Female
Neoplasms by Site
Therapeutic Uses
Peritoneal Diseases
Alkylating Agents
Endocrine Gland Neoplasms
Ovarian Neoplasms

Digestive System Neoplasms
Mitosis Modulators
Genital Neoplasms, Female
Endocrine System Diseases
Enzyme Inhibitors
Antimitotic Agents
Carboplatin
Abdominal Neoplasms
Immunosuppressive Agents
Pharmacologic Actions
Adnexal Diseases
Neoplasms
Digestive System Diseases
Paclitaxel
Tubulin Modulators

ClinicalTrials.gov processed this record on May 07, 2009