Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer

This study has been terminated.
Sponsor:
Collaborator:
Information provided by:
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT00004221
First received: January 28, 2000
Last updated: April 10, 2013
Last verified: April 2010
  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
Primary Peritoneal Cavity Cancer
Biological: filgrastim
Drug: carboplatin
Drug: cyclophosphamide
Drug: paclitaxel
Drug: topotecan hydrochloride
Procedure: peripheral blood stem cell transplantation
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: 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

Resource links provided by NLM:


Further study details as provided by Gynecologic Oncology Group:

Study Start Date: November 1999
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
Study Chair: Russell J. Schilder, MD Fox Chase Cancer Center
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004221     History of Changes
Other Study ID Numbers: CDR0000067462, GOG-9903
Study First Received: January 28, 2000
Last Updated: April 10, 2013
Health Authority: United States: Federal Government

Keywords provided by Gynecologic Oncology Group:
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
primary peritoneal cavity cancer

Additional relevant MeSH terms:
Adnexal Diseases
Digestive System Diseases
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Ovarian Diseases
Peritoneal Diseases
Ovarian Neoplasms
Peritoneal Neoplasms
Abdominal Neoplasms
Digestive System Neoplasms
Endocrine Gland Neoplasms
Genital Neoplasms, Female
Neoplasms
Neoplasms by Site
Urogenital Neoplasms
Carboplatin
Cyclophosphamide
Paclitaxel
Topotecan
Alkylating Agents
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators

ClinicalTrials.gov processed this record on October 23, 2014