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Fallopian Tube CarcinomaPhase 1NCT00060359

Polyglutamate Paclitaxel and Carboplatin in Treating Patients With Ovarian Epithelial, Peritoneal, or Fallopian Tube Cancer

A Phase 1 study testing Carboplatin, Paclitaxel Poliglumex and Pharmacological Study in people with Fallopian Tube Carcinoma and Malignant Ovarian Mixed Epithelial Tumor, run by Gynecologic Oncology Group at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Carboplatin, Paclitaxel Poliglumex and Pharmacological Study
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
Apr 2003to Jan 2009
Phase
Phase 1
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 ovarian epithelial, primary peritoneal, or fallopian tube carcinoma
  • Stage III or IV
  • Optimal (no greater than 1 cm) or suboptimal residual disease after initial surgery
  • The following histologic epithelial cell types are eligible:
  • Serous adenocarcinoma
  • Mucinous adenocarcinoma
Show all 40Show fewer
  • Clear cell adenocarcinoma
  • Transitional cell carcinoma
  • Adenocarcinoma not otherwise specified
  • Endometrioid adenocarcinoma
  • Undifferentiated carcinoma
  • Mixed epithelial carcinoma
  • Malignant Brenner tumor
  • No epithelial tumors of low malignant potential (borderline tumors)
  • Surgery performed within the past 12 weeks
  • Performance status - GOG 0-2
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • No active bleeding
  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2.5 times ULN (5 times ULN if liver metastasis)
  • Alkaline phosphatase no greater than 2.5 times ULN (5 times ULN if liver metastasis)
  • No acute hepatitis
  • PT and PTT normal
  • Creatinine no greater than 1.5 times ULN
  • Cardiac conduction abnormalities (e.g., bundle branch block or heart block) allowed provided cardiac status has been stable for the past 6 months
  • No myocardial infarction within the past 6 months
  • No unstable angina
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • No neuropathy (sensory or motor) grade 2 or worse
  • No other invasive malignancies within the past 5 years except nonmelanoma skin cancer or localized breast cancer
  • No active infection requiring antibiotics
  • No circumstances that would preclude study completion or follow-up
  • More than 3 years since prior adjuvant chemotherapy for localized breast cancer (must be free of recurrent or metastatic disease)
  • More than 3 years since prior radiotherapy for localized cancer of the breast, head and neck, or skin (must be free of recurrent or metastatic disease)
  • No prior radiotherapy to any portion of the abdominal cavity or pelvis
  • No prior treatment, other than debulking surgery, for this cancer
  • No prior treatment for another cancer that would contraindicate this protocol therapy
  • No concurrent amifostine or other protective reagents

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

Other trials in United States

About this study

Official title: A Dose-Escalating Phase I Study With an Expanded Cohort to Assess the Feasibility of CT-2103 and Carboplatin (NSC #214240) in Patients With Previously Untreated Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Carcinoma

This phase I trial is studying the side effects and best dose of polyglutamate paclitaxel when given together with carboplatin in treating patients with ovarian epithelial, peritoneal, or fallopian tube cancer. Drugs used in chemotherapy such as polyglutamate paclitaxel and carboplatin use different ways to stop tumor cells from dividing so they stop growing or die. Polyglutamate paclitaxel may be able to deliver the drug directly to tumor cells while leaving normal cells undamaged. Combining polyglutamate paclitaxel with carboplatin may kill more tumor cells.

Read the detailed description

PRIMARY OBJECTIVES:

  1. Determine the maximum tolerated dose (MTD) of polyglutamate paclitaxel in combination with carboplatin in patients with chemotherapy-naïve ovarian epithelial, primary peritoneal, or fallopian tube carcinoma.

II. Determine the feasibility of this regimen at the MTD in an expanded cohort of patients.

III. Determine the response rate and progression-free survival of patients treated with this regimen in the expanded cohort.

IV. Determine the toxicity profile of this regimen in these patients. V. Determine the pharmacokinetics and pharmacodynamics of this drug combination in these patients.

OUTLINE: This is an open-label, multicenter, dose-escalation study of polyglutamate paclitaxel (CT-2103) followed by a feasibility, multicenter study.

DOSE-ESCALATION PHASE: Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of CT-2103 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment.

FEASIBILITY PHASE: Once the MTD of CT-2103 is determined, an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Being tested
Carboplatin, Paclitaxel Poliglumex, Pharmacological Study
Medical subject headings
Fallopian Tube Neoplasms, Brenner Tumor, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CarboplatinDrug

    Also called Blastocarb, Carboplat, Carboplatin Hexal, Carboplatino

    Given IV

  • Paclitaxel PoliglumexDrug

    Also called CT-2103, Paclitaxel Polyglutamate, Paclitaxel-Polyglutamate Polymer, PG-TXL

    Given IV

  • Pharmacological StudyOther

    Correlative studies

Study groups in NCT00060359
Study groupRoleWhat they receive
Treatment (paclitaxel poliglumex, carboplatin)ExperimentalDOSE-ESCALATION PHASE: Patients receive CT-2103 IV over 10 minutes and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of CT-2103 until the MTD is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity during the first course of treatment. FEASIBILITY PHASE: Once the MTD of CT-2103 is determined, an additional 20-40 patients receive treatment at that dose level combined with carboplatin as above.
Receives: Drug: Carboplatin; Drug: Paclitaxel Poliglumex; Other: Pharmacological Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0

    Measured: 84 days (first 4 courses)

  2. Maximum tolerated dose (MTD) as assessed by CTC version 2.0

    Measured: 21 days

Secondary outcomes (4)

  1. Incidence of cumulative toxicity

    Measured: 168 days (8 courses)

  2. Pharmacokinetics and pharmacodynamics of conjugated taxanes, unconjugated paclitaxel and carboplatin, as assessed by serum and urine measurements

    Measured: 84 days (courses 1-4)

  3. Progression-free survival

    Measured: Up to 5 years

  4. Response

    Measured: Up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionJan 2009

Resources

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 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00060359
Sponsor's protocol ID
GOG-9914
Other IDs
NCI-2012-02532, CDR0000301642, GOG-9914, GOG-9914, U10CA027469
Status last verified
May 2015
First submitted
6 May 2003
Last updated
8 May 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Carboplatin, Paclitaxel Poliglumex and Pharmacological Study in people with Fallopian Tube Carcinoma and Malignant Ovarian Mixed Epithelial Tumor, run by Gynecologic Oncology Group at 1 site 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 40 inclusion and 0 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 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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.

What does the primary outcome measure?

Feasibility, in terms of incidence of DLT, as assessed by CTC version 2.0 (time frame: 84 days (first 4 courses)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00060359.

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 8 May 2015; AzTrials last refreshed its copy on 8 Nov 2026.

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