NCT00003880

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with gene therapy using SCH-58500 may kill more tumor cells. PURPOSE: Randomized phase II/III trial to determine the effectiveness of paclitaxel plus carboplatin with or without SCH-58500 in treating patients who have newly diagnosed stage III ovarian or stage III primary peritoneal cancer with residual disease following surgery to remove the tumor.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P75+ for phase_2 ovarian-cancer

Timeline
Completed

Started Feb 1999

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 1999

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2001

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

April 23, 2004

Completed
Last Updated

April 16, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

November 1, 1999

Last Update Submit

April 15, 2015

Conditions

Ovarian CancerPrimary Peritoneal Cavity Cancer

Keywords

stage III ovarian epithelial cancerovarian mixed epithelial carcinomaovarian serous cystadenocarcinomaovarian mucinous cystadenocarcinomaovarian endometrioid adenocarcinomaovarian clear cell cystadenocarcinomaprimary peritoneal cavity cancer

Interventions

recombinant adenovirus-p53 SCH-58500BIOLOGICAL
carboplatinDRUG
paclitaxelDRUG

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Histologically confirmed stage III ovarian epithelial or primary peritoneal cancer with residual disease no greater than 2 cm following cytoreductive surgery The following cell types are eligible: Serous adenocarcinoma, mucinous adenocarcinoma, clear cell adenocarcinoma, transitional cell, adenocarcinoma NOS, endometrioid adenocarcinoma, mixed epithelial carcinoma, or peritoneal serous papillary carcinoma Total abdominal hysterectomy with salpingo-oophorectomy or supracervical hysterectomy, omentectomy, tumor reduction, lymph node assessment, and debulking if nodes 2 cm or greater No endometrial malignancy treated with supracervical hysterectomy No cytologically positive pleural effusion No tumors of borderline histology No cancer of the fallopian tubes PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 80-100% Life expectancy: Not specified Hematopoietic: Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) SGOT no greater than 2 times ULN Alkaline phosphatase no greater than 2 times ULN Renal: Creatinine no greater than 2 mg/dL Glomerular filtration rate no less than 30 Other: HIV negative Not pregnant or nursing Fertile patients must use effective contraception No other serious medical condition No other prior malignancies except carcinoma in situ of the cervix, nonmelanomatous skin cancer, Dukes A colorectal cancer from which patient has been disease free for past 5 years, or stage I or II breast cancer from which patient has been disease free for past 10 years PRIOR CONCURRENT THERAPY: Biologic therapy: Concurrent cytokine therapy allowed Chemotherapy: No more than 1 prior chemotherapy course for ovarian or peritoneal cancer At least 10 years since prior adjuvant chemotherapy for breast cancer Endocrine therapy: At least 3 months since prior systemic corticosteroid or other immunosuppressive therapy Concurrent female hormonal replacement allowed Radiotherapy: No prior radiotherapy for ovarian or peritoneal cancer No prior radiotherapy to abdomen Surgery: Prior surgery allowed Other: No other concurrent investigational drugs

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Ovarian NeoplasmsCarcinoma, Ovarian Epithelial

Interventions

CarboplatinPaclitaxel

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal DisordersCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsDiterpenesTerpenes

Study Officials

  • Jo Ann Horowitz, MD

    Schering-Plough

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 1999

First Posted

April 23, 2004

Study Start

February 1, 1999

Primary Completion

August 1, 2001

Study Completion

August 1, 2001

Last Updated

April 16, 2015

Record last verified: 2015-04