Ovarian NeoplasmPhase 2NCT00069901
Phase II CT-2103/Carboplatin in Ovarian Cancer
A Phase 2 study testing CT-2103 (poly(L)glutamate-paclitaxel) and carboplatin in people with Ovarian Neoplasm, run by CTI BioPharma at 17 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Neoplasm
- What is being tested?
- CT-2103 (poly(L)glutamate-paclitaxel) and carboplatin
- How many people
- 82 participants
- Where
- 17 sitesUnited States
- Study dates
- Feb 2003to Sep 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
- Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
- ECOG performance score of 0, 1, or 2.
- absolute neutrophil count (ANC) at least 1,500/µL.
- platelet at least 100,000/µL.
- hemoglobin at least 10 g/dL.
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- creatinine no greater than 1.5 times the upper limit of normal (ULN).
- bilirubin no greater than 1.5 x ULN (if liver metastases are not present, SGOT and SGPT no greater than 2.5 x ULN, if liver metastases are present, SGOT and SGPT may be no greater than 5 x ULN.
- Alkaline phosphatase no greater than 2.5 x ULN.
Who cannot join
- Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
- Synchronous primary endometrial cancer or history of primary endometrial cancer.
- Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
- Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
- Patients may have received prior adjuvant chemotherapy for localized breast cancer, if the therapy was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
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- Prior radiotherapy to any portion of the abdominal cavity or pelvis.
- Prior radiation for localized cancer of the breast, head and neck, or skin is permitted, if it was completed at least 3 years before registration in this study and if the patient remains free of recurrent or metastatic disease.
- Administration of other investigational drugs within 26 weeks before the first treatment in this study. Toxic manifestations of previous treatments (except alopecia) must have been stable for 4 weeks.
- Presence of active hepatitis, either acute or chronic.
- Presence of active infection requiring antibiotic or antiviral therapy.
- Pregnant women or nursing mothers.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Arlington Fairfax Hematology Oncology
Arlington, Virginia, 22205
Chattanooga GYN-Oncology
Chattanooga, Tennessee, 37403
South Carolina Oncology Assoicates
Columbia, South Carolina, 29203
Gynecology, Oncology, and Pelvic Surgery Associates, Inc.
Columbus, Ohio, 43222
California Cancer Care
Greenbrae, California, 94904
Gynecology Oncology Associates
Greenbrae, California
Resource Center for Gynecology/ Oncology
Kansas City, Missouri, 64132
Baptist Regional Cancer Center
Knoxville, Tennessee, 37920
University of Louisville
Louisville, Kentucky, 40202
Aurora Health Care, Inc.
Milwaukee, Wisconsin, 53201
Albert Einstein Cancer Center
Philadelphia, Pennsylvania, 19141
Upstate New York Cancer Research and Education Foundation
Rochester, New York, 98104
Guthrie Foundation for Education and Research
Sayre, Pennsylvania, 18840
Pacific Gynecology Specialists
Seattle, Washington, 98104
Swedish Cancer Institute
Seattle, Washington, 98104
Raben and Fldman Research Associates
South Miami, Florida, 33143
Stockton Hematology Oncology Medical
Stockton, California, 95204
About this study
Official title: CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study
The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.
Read the detailed description
CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.
- Conditions
- Ovarian Neoplasm
- Being tested
- CT-2103 (poly(L)glutamate-paclitaxel), carboplatin
- Keywords
- ovarian cancer, paclitaxel, carboplatin
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-2103 (poly(L)glutamate-paclitaxel)Drug
carboplatinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2003 (estimated)
- Study startFeb 2003
- Primary completionNov 2005
- Study completionSep 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- CTI BioPharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Scott Stromatt, M.D., Study director, CTI BioPharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00069901
- Sponsor's protocol ID
- PGT201
- Status last verified
- Sep 2008
- First submitted
- 2 Oct 2003
- Last updated
- 22 Sep 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CT-2103/Carboplatin for Patients With Newly Diagnosed Stage III or IV Ovarian or Primary Peritoneal Cancer: A Phase 2 Study
- ClinicalTrials.gov ID
- NCT00069901
- Acronym / sponsor ID
- PGT201
- Conditions
- Ovarian Neoplasm
- Keywords
- ovarian cancer, paclitaxel, carboplatin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- CTI BioPharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2003
- Primary completion
- Nov 2005 (actual)
- Study completion
- Sep 2006 (actual)
- First posted
- 6 Oct 2003 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and efficacy of CT-2103 (poly(L)glutamate-paclitaxel) in combination with carboplatin for the treatment of patients with Stage III or IV ovarian or primary peritoneal cancer.
Detailed description
CT-2103 is a pharmaceutical that links paclitaxel, the active ingredient in Taxol(R), to a biodegradable polyglutamate polymer. The objective of this trial is to evaluate the toxicity, estimate the response rate, progression-free survival and overall survival in patients with newly diagnosed stage III or IV ovarian or primary peritoneal carcinoma treated with CT-2103 in combination with carboplatin.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically-confirmed stage III or IV ovarian carcinoma or primary peritoneal cancer patients who have had appropriate debulking surgery for ovarian or peritoneal carcinoma.
- Patients must be recovered from initial surgery and must enter this study no later than 12 weeks after such surgery.
- ECOG performance score of 0, 1, or 2.
- absolute neutrophil count (ANC) at least 1,500/µL.
- platelet at least 100,000/µL.
Key exclusion criteria (12 listed)
- Current diagnosis of epithelial ovarian tumor of low malignant potential (borderline carcinomas)
- Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or carcinosarcomas, metastatic carcinomas from sites other than the ovary, and low malignant potential tumors including so called micropapillary serous carcinomas.
- Synchronous primary endometrial cancer or history of primary endometrial cancer.
- Evidence of any other invasive malignancies present within the 3 years before this study, with the exception of non-melanoma skin cancer and other specific malignancies as noted above.
- Any prior treatment, other than initial debulking surgery, for the cancer being treated in this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-2103 (poly(L)glutamate-paclitaxel) | Drug | – |
| carboplatin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Scott Stromatt, M.D. study director
CTI BioPharma
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CT-2103 (poly(L)glutamate-paclitaxel) and carboplatin in people with Ovarian Neoplasm, run by CTI BioPharma at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2008.