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A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy

Phase 3
Open (Enrolling)
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

Trial Information

A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or Xyotax (CT-2103) (IND# 70177), Versus No Treatment Until Documented Relapse in Women With Advanced Ovarian or Primary Peritoneal or Fallopian Tube Cancer Who Achieve a Complete Clinical Response to Primary Platinum/Taxane Chemotherapy



- Compare overall survival of patients with stage III or IV ovarian epithelial or primary
peritoneal cancer or fallopian tube cancer in clinical complete response after prior
primary platinum and taxane-based chemotherapy treated with paclitaxel vs polyglutamate
paclitaxel as consolidation/maintenance therapy vs no further anticancer therapy until
documented disease progression.


- Compare progression-free survival of patients treated with these drugs.

- Compare the toxicity profile of these drugs, particularly peripheral neuropathy, in
these patients.

- Compare the quality of life of patients treated with these drugs.


- Correlate angiogenic marker expression with overall or progression-free survival of
patients treated with these drugs.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
disease stage at diagnosis (stage III vs stage IV); presence of macroscopic disease after
initial debulking surgery (yes vs no); type of prior taxane-based therapy (docetaxel vs
paclitaxel); and route of prior platinum therapy (intraperitoneal vs IV). Patients are
randomized to 1 of 3 treatment arms.

- Arm I: Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.

- Arm II: Patients receive paclitaxel IV over 3 hours on day 1.

- Arm III: Patients receive no further anticancer treatment until evidence of disease

In arms I and II, treatment repeats every 28 days for up to 12 courses in the absence of
disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before courses 3, 5, and 7 of study treatment, at
completion of study treatment, and then at 1 year after completion of study treatment.

After completion of study treatment, patients are followed every 3 months for 2 years and
then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 1,110 patients (555 per treatment arm) will be accrued for
this study within 8.5 years.

Inclusion Criteria


- Histologically confirmed stage III or IV ovarian epithelial or primary peritoneal
cancer or fallopian tube cancer

- The following histologic epithelial cell types are allowed:

- Serous adenocarcinoma

- Endometrioid adenocarcinoma

- Mucinous adenocarcinoma

- Undifferentiated carcinoma

- Clear cell adenocarcinoma

- Mixed epithelial carcinoma

- Transitional cell carcinoma

- Malignant Brenner tumor

- Adenocarcinoma not otherwise specified

- The following histologic cell types are not allowed:

- Germ cell tumor

- Sex cord-stromal tumor

- Carcinosarcoma

- Mixed müllerian tumor or carcinosarcoma

- Metastatic carcinoma from other sites to the ovary

- Low malignant potential (LMP) tumor (borderline carcinoma), including
micropapillary serous carcinoma

- Patients with a prior diagnosis of LMP tumor that was surgically resected
and who subsequently developed invasive adenocarcinoma are eligible
provided patient did not receive prior chemotherapy for the ovarian LMP

- Must have undergone surgery for ovarian epithelial or primary peritoneal cancer AND
have tissue available for histologic evaluation

- Optimal (≤ 1 cm) residual disease OR suboptimal residual disease after initial

- Must have completed at least 5, but no more that 8 courses of primary therapy
comprising carboplatin (IV or intraperitoneal) AND paclitaxel or docetaxel-based
combination chemotherapy within the past 12 weeks AND have no symptoms of persistent
cancer after completion of therapy

- CT scan of the abdomen and/or pelvis normal

- CA 125 normal

- Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive
diagnosis of stage III or IV primary peritoneal carcinoma or epithelial ovarian
carcinoma (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided
the following criteria is met:

- Must have undergone interval abdominal surgery after at least one but no more
than 6 courses of standard chemotherapy

- Surgery must meet the same criteria as the up front surgery, including
tissue diagnosis for confirmation of primary tumor site and stage III or IV

- Patients must have received at least 2 courses after interval abdominal

- No synchronous primary endometrial cancer or history of primary endometrial cancer,
unless all of the following criteria are met:

- Stage ≤ IB

- Less than 3 mm invasion without vascular or lymphatic invasion

- No poorly differentiated subtypes, including papillary serous, clear cell, or
other FIGO grade 3 lesion



- Not specified

Performance status

- GOG 0-2

Life expectancy

- Not specified


- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- No active bleeding


- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- SGOT ≤ 2.5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN

- PT or PTT normal

- No acute or chronic hepatitis


- Creatinine ≤ 1.5 times ULN


- Abnormal cardiac conduction (e.g., bundle branch block or heart block) allowed
provided the disease has remained stable within the past 6 months

- No unstable angina

- No myocardial infarction within the past 6 months


- No neuropathy (sensory and motor) ≥ grade 2

- No active infection requiring antibiotics

- No ongoing gastrointestinal bleeding requiring blood product support

- No circumstance that would preclude study participation

- No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

- Not pregnant or nursing

- Fertile patients must agree to use an effective contraception method

- Negative pregnancy test


Biologic therapy

- No prior biologic therapy (e.g., bevacizumab or erlotinib) for any other abdominal or
pelvic tumor


- See Disease Characteristics

- No prior polyglutamate paclitaxel

- No prior chemotherapy for any other abdominal or pelvic tumor

- More than 3 years since prior adjuvant chemotherapy for localized breast cancer AND
no recurrent or metastatic disease

Endocrine therapy

- Not specified


- No prior radiotherapy to any portion of the abdominal cavity or pelvis

- More than 3 years since prior radiotherapy for localized cancer of the breast, head
and neck, or skin AND no recurrent or metastatic disease


- See Disease Characteristics


- No prior investigational therapy for any other abdominal or pelvic tumor

- No prior anticancer therapy that would preclude study therapy

- No concurrent amifostine or other protective agents

Type of Study:


Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Safety Issue:


Principal Investigator

Larry J. Copeland, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Ohio State University Comprehensive Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

March 2005

Completion Date:

Related Keywords:

  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Primary Peritoneal Cavity Cancer
  • stage IV ovarian epithelial cancer
  • ovarian clear cell cystadenocarcinoma
  • ovarian endometrioid adenocarcinoma
  • ovarian mixed epithelial carcinoma
  • ovarian mucinous cystadenocarcinoma
  • ovarian serous cystadenocarcinoma
  • Brenner tumor
  • ovarian undifferentiated adenocarcinoma
  • stage IIIA fallopian tube cancer
  • stage IIIB fallopian tube cancer
  • stage IIIC fallopian tube cancer
  • stage IIIA primary peritoneal cavity cancer
  • stage IIIB primary peritoneal cavity cancer
  • stage IIIC primary peritoneal cavity cancer
  • stage IV primary peritoneal cavity cancer
  • stage IIIA ovarian epithelial cancer
  • stage IIIB ovarian epithelial cancer
  • stage IIIC ovarian epithelial cancer
  • stage IV fallopian tube cancer
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms



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