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

NCT ID: NCT00004221

Last Updated: 2017-08-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1999-11-30

Brief Summary

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. 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.

Detailed Description

OBJECTIVES:

I. 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.

II. 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 sub-cutaneously (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.

Conditions

Malignant Ovarian Mixed Epithelial Tumor; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mucinous Cystadenocarcinoma; Ovarian Serous Cystadenocarcinoma; Primary Peritoneal Carcinoma; Stage III Ovarian Cancer; Undifferentiated Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (Combination chemotherapy, PBSC)

See detailed description.

Group Type: EXPERIMENTAL

Carboplatin

Intervention Type: DRUG

Given IV

Cyclophosphamide

Intervention Type: DRUG

Given IV

Filgrastim

Intervention Type: BIOLOGICAL

Given SQ

Paclitaxel

Intervention Type: DRUG

Given IV

Peripheral Blood Stem Cell Transplantation

Intervention Type: PROCEDURE

Undergo autologous peripheral blood stem cell transplantation

Topotecan Hydrochloride

Intervention Type: DRUG

Given IV

Interventions

Carboplatin

Given IV

Intervention Type: DRUG

Cyclophosphamide

Given IV

Intervention Type: DRUG

Filgrastim

Given SQ

Intervention Type: BIOLOGICAL

Paclitaxel

Given IV

Intervention Type: DRUG

Peripheral Blood Stem Cell Transplantation

Undergo autologous peripheral blood stem cell transplantation

Intervention Type: PROCEDURE

Topotecan Hydrochloride

Given IV

Intervention Type: DRUG

Other Intervention Names

Blastocarb; Carboplat; Carboplatin Hexal; Carboplatino; Carbosin; Carbosol; Carbotec; CBDCA; Displata; Ercar; JM-8; Nealorin; Novoplatinum; Paraplat; Paraplatin; Paraplatin AQ; Paraplatine; Platinwas; Ribocarbo; (-)-Cyclophosphamide; 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate; Carloxan; Ciclofosfamida; Ciclofosfamide; Cicloxal; Clafen; Claphene; CP monohydrate; CTX; CYCLO-cell; Cycloblastin; Cycloblastine; Cyclophospham; Cyclophosphamid monohydrate; Cyclophosphamidum; Cyclophosphan; Cyclophosphane; Cyclophosphanum; Cyclostin; Cyclostine; Cytophosphan; Cytophosphane; Cytoxan; Fosfaseron; Genoxal; Genuxal; Ledoxina; Mitoxan; Neosar; Revimmune; Syklofosfamid; WR- 138719; Filgrastim XM02; G-CSF; Neupogen; r-metHuG-CSF; Recombinant Methionyl Human Granulocyte Colony Stimulating Factor; rG-CSF; Tbo-filgrastim; Tevagrastim; Anzatax; Asotax; Bristaxol; Praxel; Taxol; Taxol Konzentrat; PBPC transplantation; Peripheral Blood Progenitor Cell Transplantation; Peripheral Stem Cell Support; Peripheral Stem Cell Transplantation; Hycamptamine; Hycamtin; SKF S-104864-A; Topotecan HCl; topotecan hydrochloride (oral)

Eligibility Criteria

Inclusion Criteria

• 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
• Performance status - GOG 0 or 1
• Absolute neutrophil count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3
• Bilirubin no greater than 1.5 mg/dL
• SGOT or SGPT no greater than 2 times upper limit of normal
• No active hepatitis
• Creatinine no greater than 1.5 mg/dL
• Creatinine clearance at least 60 mL/min
• No renal failure
• Curatively treated ureteral obstruction allowed if above creatinine measurements met
• 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)
• No significant nonneoplastic pulmonary disease
• 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
• No prior chemotherapy for this malignancy
• No radiotherapy to greater than 25% of bone marrow
• See Disease Characteristics

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Gynecologic Oncology Group

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Russell Schilder

Role: PRINCIPAL_INVESTIGATOR

Gynecologic Oncology Group

Locations

Gynecologic Oncology Group

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

NCI-2012-02312

Identifier Type: REGISTRY

Identifier Source: secondary_id

CDR0000067462

Identifier Type: -

Identifier Source: secondary_id

GOG-9903

Identifier Type: OTHER

Identifier Source: secondary_id

GOG-9903

Identifier Type: OTHER

Identifier Source: secondary_id

U10CA027469

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GOG-9903

Identifier Type: -

Identifier Source: org_study_id