Clinical trial · Interventional

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

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

NCT00004221CI-TRIAL-00028995terminatedPhase 2ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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.

Conditions

Conditions (8)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Malignant Ovarian Mixed Epithelial Tumor	Ovarian Neoplasm	PROBABILISTIC	0.70
Ovarian Clear Cell Cystadenocarcinoma	Ovarian Clear Cell Cystadenocarcinoma	ONTOLOGY_EXACT	0.98
Ovarian Endometrioid Adenocarcinoma	Ovarian Endometrioid Adenocarcinoma	ONTOLOGY_EXACT	0.98
Ovarian Mucinous Cystadenocarcinoma	Ovarian Mucinous Cystadenocarcinoma	ONTOLOGY_EXACT	0.98
Ovarian Serous Cystadenocarcinoma	Ovarian Serous Cystadenocarcinoma	ONTOLOGY_EXACT	0.98
Primary Peritoneal Carcinoma	Primary Peritoneal Carcinoma	ONTOLOGY_EXACT	0.98
Stage III Ovarian Cancer	Malignant Ovarian Neoplasm

Interventions

Interventions (6)

Intervention	Type	Mapped drug	Match
Carboplatin	Drug	Carboplatin	ALIAS
Cyclophosphamide	Drug	Cyclophosphamide	ALIAS
Filgrastim	Biological	Filgrastim	ALIAS
Paclitaxel	Drug	Paclitaxel	ALIAS
Peripheral Blood Stem Cell Transplantation	Procedure	—	UNRESOLVED
Topotecan Hydrochloride	Drug	Topotecan	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
Treatment (Combination chemotherapy, PBSC)
description
See detailed description.
interventionNames
1. Drug: Carboplatin
2. Drug: Cyclophosphamide
3. Biological: Filgrastim
4. Drug: Paclitaxel
5. Procedure: Peripheral Blood Stem Cell Transplantation
6. Drug: Topotecan Hydrochloride

Primary outcomes (2)

measure
Complete response defined as complete disappearance of all measurable and evaluable tumor documented at second-look surgery
timeFrame
Up to 11 years
measure
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)
timeFrame

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Nov 1, 1999
Primary completion: Feb 6, 2002
Completion: —
First posted: Aug 25, 2003
Last update posted: Aug 9, 2017
Enrollment: 12 (actual)
Lead sponsor: Gynecologic Oncology Group NETWORK
Collaborators: National Cancer Institute (NCI)

Data updated 22 days agoSource updated Aug 9, 2017source: clinicaltrials

Locations

Locations by country (1)

Country	Sites	Recruiting
United States	1	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.