Clinical trial · Interventional

S0009 Combination Chemo and Surgery in Stage III or Stage IV Ovarian Cancer

Phase II Evaluation Of Neoadjuvant Chemotherapy, Interval Debulking Followed By Intraperitoneal Chemotherapy In Women With Stage III And IV Epithelial Ovarian Cancer, Fallopian Tube Cancer Or Primary Peritoneal Cancer

NCT00008138CI-TRIAL-00020476S0009completedPhase 2Results postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug or combining chemotherapy with surgery may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy and surgery in treating patients who have stage III or stage IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer.

Conditions

Conditions (3)

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

Condition (as posted)	Mapped entity	Match	Confidence
Fallopian Tube Cancer	Malignant Fallopian Tube Neoplasm	ALIAS	0.90
Ovarian Cancer	Malignant Ovarian Neoplasm	CURATED_EXACT	0.92
Peritoneal Cavity Cancer	Malignant Peritoneal Neoplasm	ALIAS	0.90

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
carboplatin	Drug	Carboplatin	ALIAS
debulking surgery	Procedure	—	UNRESOLVED
paclitaxel	Drug	Paclitaxel	ALIAS

Design

Arms and outcomes

Arms (1)

type
EXPERIMENTAL
label
chemo/debulking surgery/IP chemo
description
neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
interventionNames
1. Drug: carboplatin
2. Drug: paclitaxel
3. Procedure: debulking surgery

Primary outcomes (2)

measure
Overall Survival
timeFrame
assessed every 3 months for 1st year, then every 6 months for 2 years, then annually for years 4 and 5
description
Overall survival was defined as the time from the date of registration until the date of death due to any cause. Patients last known to be alive were censored at the date of last contact. Patients were followed every 3 months for the first year, every 6 months for years 2 and 3, and then annually for years 4 and 5.
measure

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years
Maximum age: 120 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed stage III or IV ovarian epithelial cancer, primary peritoneal cancer, or fallopian tube cancer

  * Adenocarcinoma
  * Large pelvic mass and/or bulky abdominal disease and/or malignant pleural effusion
  * Pleural effusion only for stage IV (parenchymal, liver, lung, or other distant metastases not allowed)
  * No borderline or low-malignant potential tumors
* Optimal cytoreduction clinically deemed unlikely
* CA 125 at least 70 units/mL

PATIENT CHARACTERISTICS:

Age:

* Not specified

Performance status:

* Zubrod 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than 2 times upper limit of normal (ULN)
* SGOT no greater than 2 times ULN

Renal:

* Creatinine clearance at least 50 mL/min

Cardiovascular:

* No congestive heart failure or cardiac arrhythmia
* No myocardial infarction or angina within past 6 months

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception
* No severe gastrointestinal symptoms (i.e., partial obstruction) and/or gastrointestinal bleeding
* No grade 2 or greater sensory neuropathy
* No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or other adequately treated stage I or II cancer in complete remission
* No active or uncontrolled infection

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No prior immunotherapy for this cancer

Chemotherapy:

* No prior chemotherapy for this cancer

Endocrine therapy:

* Not specified

Radiotherapy:

* No prior pelvic radiation for this cancer

Surgery:

* See Disease Characteristics
* Prior exploratory laparotomy allowed provided an aggressive tumor debulking procedure was not performed (e.g., bilateral salpingo-oophorectomy/total abdominal hysterectomy with omentectomy)
* Prior salpingo-oophorectomy and/or partial omentectomy allowed

Other:

* No other concurrent anti-cancer therapy

References

Publications (1)

RESULTTiersten AD, Liu PY, Smith HO, Wilczynski SP, Robinson WR 3rd, Markman M, Alberts DS. Phase II evaluation of neoadjuvant chemotherapy and debulking followed by intraperitoneal chemotherapy in women with stage III and IV epithelial ovarian, fallopian tube or primary peritoneal cancer: Southwest Oncology Group Study S0009. Gynecol Oncol. 2009 Mar;112(3):444-9. doi: 10.1016/j.ygyno.2008.10.028. Epub 2009 Jan 12. PMID 19138791

Registry

Dates and enrollment

Start: Mar 1, 2001
Primary completion: Sep 1, 2009
Completion: Nov 1, 2009
First posted: Jan 27, 2003
Last update posted: Jan 8, 2016
Results first posted: Aug 24, 2012
Enrollment: 62 (actual)
Lead sponsor: SWOG Cancer Research Network NETWORK
Collaborators: National Cancer Institute (NCI)
Keywords: stage III ovarian epithelial cancer, stage IV ovarian epithelial cancer, ovarian undifferentiated adenocarcinoma, ovarian serous cystadenocarcinoma, ovarian mucinous cystadenocarcinoma, ovarian endometrioid adenocarcinoma, ovarian clear cell cystadenocarcinoma, fallopian tube cancer, peritoneal cavity cancer

Data updated 22 days agoSource updated Jan 8, 2016source: clinicaltrials

Locations

Locations by country (0)

No location posted.

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