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

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Primary Purpose

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Carboplatin

Cyclophosphamide

Filgrastim

Paclitaxel

Peripheral Blood Stem Cell Transplantation

Topotecan Hydrochloride

About this trial

This is an interventional treatment trial for Malignant Ovarian Mixed Epithelial Tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Gynecologic Oncology Group

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (Combination chemotherapy, PBSC)

Arm Description

See detailed description.

Outcomes

Primary Outcome Measures

Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery

Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic)

Secondary Outcome Measures

Overall survival

PFS

Full Information

NCT ID

NCT00004221

First Posted

January 28, 2000

Last Updated

August 8, 2017

Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00004221

Brief Title

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

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 and Primary Peritoneal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

August 2017

Overall Recruitment Status

Terminated

Study Start Date

November 1999 (undefined)

Primary Completion Date

February 6, 2002 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gynecologic Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Treatment (Combination chemotherapy, PBSC)

Arm Type

Experimental

Arm Description

See detailed description.

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Other Intervention Name(s)

Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino, Carbosin, Carbosol, Carbotec, CBDCA, Displata, Ercar, JM-8, Nealorin, Novoplatinum, Paraplat, Paraplatin, Paraplatin AQ, Paraplatine, Platinwas, Ribocarbo

Intervention Description

Given IV

Intervention Type

Drug

Intervention Name(s)

Cyclophosphamide

Other Intervention Name(s)

(-)-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

Intervention Description

Given IV

Intervention Type

Biological

Intervention Name(s)

Filgrastim

Other Intervention Name(s)

Filgrastim XM02, G-CSF, Neupogen, r-metHuG-CSF, Recombinant Methionyl Human Granulocyte Colony Stimulating Factor, rG-CSF, Tbo-filgrastim, Tevagrastim

Intervention Description

Given SQ

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Other Intervention Name(s)

Anzatax, Asotax, Bristaxol, Praxel, Taxol, Taxol Konzentrat

Intervention Description

Given IV

Intervention Type

Procedure

Intervention Name(s)

Peripheral Blood Stem Cell Transplantation

Other Intervention Name(s)

PBPC transplantation, Peripheral Blood Progenitor Cell Transplantation, Peripheral Stem Cell Support, Peripheral Stem Cell Transplantation

Intervention Description

Undergo autologous peripheral blood stem cell transplantation

Intervention Type

Drug

Intervention Name(s)

Topotecan Hydrochloride

Other Intervention Name(s)

Hycamptamine, Hycamtin, SKF S-104864-A, Topotecan HCl, topotecan hydrochloride (oral)

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery

Time Frame

Up to 11 years

Title

Indication of excessive toxicity defined as hospitalization > 14 days per course, delay of day 1 therapy > 14 days, or grade 3 (irreversible) or grade 4 vital organ toxicity (non-hematologic)

Time Frame

Up to 11 years

Secondary Outcome Measure Information:

Title

Overall survival

Time Frame

Up to 11 years

Title

PFS

Time Frame

Up to 11 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Russell Schilder

Organizational Affiliation

Gynecologic Oncology Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

Gynecologic Oncology Group

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19103

Country

United States

Malignant Ovarian Mixed Epithelial Tumor, Ovarian Clear Cell Cystadenocarcinoma, Ovarian Endometrioid Adenocarcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial