Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage III Ovarian Cancer
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: Carboplatin Drug: Cyclophosphamide Biological: Filgrastim Drug: Paclitaxel Procedure: Peripheral Blood Stem Cell Transplantation Drug: Topotecan Hydrochloride |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label 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 and Primary Peritoneal Carcinoma |
- Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
- PFS [ Time Frame: Up to 11 years ] [ Designated as safety issue: No ]
| Enrollment: | 12 |
| Study Start Date: | November 1999 |
| Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment (Combination chemotherapy, PBSC)
See detailed description.
|
Drug: Carboplatin
Given IV
Other Names:
Drug: Cyclophosphamide
Given IV
Other Names:
Biological: Filgrastim
Given SQ
Other Names:
Drug: Paclitaxel
Given IV
Other Names:
Procedure: Peripheral Blood Stem Cell Transplantation
Undergo autologous peripheral blood stem cell transplantation
Other Names:
Drug: Topotecan Hydrochloride
Given IV
Other Names:
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004221
| United States, Pennsylvania | |
| Gynecologic Oncology Group | |
| Philadelphia, Pennsylvania, United States, 19103 | |
| Principal Investigator: | Russell Schilder | Gynecologic Oncology Group |
More Information
| Responsible Party: | Gynecologic Oncology Group |
| ClinicalTrials.gov Identifier: | NCT00004221 History of Changes |
| Other Study ID Numbers: | GOG-9903 NCI-2012-02312 CDR0000067462 GOG-9903 GOG-9903 U10CA027469 |
| Study First Received: | January 28, 2000 |
| Last Updated: | March 17, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Ovarian Diseases Adnexal Diseases Genital Diseases, Female Endocrine System Diseases Gonadal Disorders Carcinoma Adenocarcinoma Ovarian Neoplasms Cystadenocarcinoma Carcinoma, Endometrioid Cystadenocarcinoma, Serous Cystadenocarcinoma, Mucinous Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms |
Endocrine Gland Neoplasms Neoplasms by Site Genital Neoplasms, Female Urogenital Neoplasms Neoplasms, Cystic, Mucinous, and Serous Endometrial Neoplasms Uterine Neoplasms Paclitaxel Albumin-Bound Paclitaxel Cyclophosphamide Carboplatin Topotecan Lenograstim Antineoplastic Agents, Phytogenic Antineoplastic Agents |
ClinicalTrials.gov processed this record on September 27, 2016