Skip to content

Trial · Interventional

Status unknownPhase 2Registry data

Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer

NCTNCT00017303 (opens ClinicalTrials.gov in a new tab)Other idCDR0000068674Other idCYTRAN-IM862-302Other idFHCRC-5156
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Status unknown
Phase
Phase 2
Enrollment
Not stated
Sponsor
Cytran · Industry
Design
Not stated
Countries
1 country

United States

Start
Jan 2001
Primary completion
Not stated
Completion
Not stated
First posted
27 Feb 2004 (estimated)
Last update posted
6 Nov 2013 (estimated)
Conditions
Ovarian Cancer · Primary Peritoneal Cavity Cancer

Timeline

1 trial

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20012002
  1. Ph 2

    Combination Chemotherapy Plus IM-862 in Treating Patients With Resected Stage III Ovarian Cancer or Primary Peritoneal Cancer

    NCT00017303

    Start Jan 2001

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. IM-862 may kill tumor cells by stopping blood flow to the tumor and by stimulating a person's white blood cells to kill tumor cells. Combining chemotherapy and IM-862 may kill more tumor cells. PURPOSE: Randomized phase II trial to study the effectiveness of combination chemotherapy and IM-862 in treating patients who have resected stage III ovarian cancer or primary peritoneal cancer.

Interventions

  • carboplatinDrug
  • oglufanide disodiumDrug
  • paclitaxelDrug
  • conventional surgeryProcedure

Arms0

The registry lists no arms for this trial.

Primary outcomes0

Outcomes the sponsor listed as primary.

The registry lists no primary outcome.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedGaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3. PMID 37185961

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
DISEASE CHARACTERISTICS: Histologically confirmed stage III ovarian epithelial cancer or primary peritoneal carcinoma of one of the following cell types: Serous adenocarcinoma Mucinous adenocarcinoma Clear-cell adenocarcinoma Endometrioid Adenocarcinoma (not otherwise specified) Undifferentiated carcinoma Transitional cell Malignant Brenner's tumor Mixed epithelial carcinoma No borderline tumor (tumor of low malignant potential) Underwent prior standard initial cytoreductive surgery within the past 6 weeks Optimally resected disease with no residual site of disease more than 1 cm in greatest dimension Removal of all disease extending beyond the reproductive tract Total hysterectomy and bilateral salpingo-oopherectomy at cytoreductive surgery or in the past PATIENT CHARACTERISTICS: Age: 18 and over Performance status: GOG 0-2 Life expectancy: Not specified Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) Alkaline phosphatase no greater than 3 times ULN SGOT no greater than 3 times ULN Renal: Creatinine no greater than 2.0 mg/dL Other: No other malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix or breast No other major systemic medical illness that would preclude survival No poor general condition or medical, social, or psychosocial factors that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: No prior biologic therapy for current malignancy At least 5 years since prior gene therapy At least 1 year since prior interleukin-2 (IL-2) At least 1 year since prior sargramostim (GM-CSF) Concurrent filgrastim (G-CSF) allowed No concurrent gene therapy No concurrent GM-CSF No concurrent IL-2 No other concurrent angiogenesis inhibitors (e.g., thalidomide, cyclooxygenase-2 inhibitors (e.g., rofecoxib or celecoxib), interferon products, or angiotensin-converting enzyme inhibitors) Chemotherapy: At least 5 years since prior anticancer chemotherapy No prior chemotherapy for current malignancy No other concurrent chemotherapy Endocrine therapy: No prior endocrine therapy for current malignancy At least 1 year since prior tamoxifen No concurrent tamoxifen Radiotherapy: No prior radiotherapy for current malignancy Surgery: See Disease Characteristics Other: At least 1 year since prior experimental or investigational medications No other concurrent experimental or investigational medications

PepBank is a research reference. Talk to a doctor before you use any peptide.