Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

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Brief Title

Paclitaxel, Polyglutamate Paclitaxel, or Observation in Treating Patients With Stage III or Stage IV Ovarian Epithelial, Peritoneal Cancer, or Fallopian Tube Cancer

Official Title

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

Brief Summary

      This randomized phase III trial studies paclitaxel to see how well it works compared to
      polyglutamate paclitaxel or observation only in treating patients with stage III or stage IV
      ovarian epithelial, peritoneal cancer, or fallopian tube cancer. Drugs used in chemotherapy,
      such as paclitaxel and polyglutamate paclitaxel, work in different ways to stop the growth of
      tumor cells, either by killing the cells or by stopping them from dividing. Paclitaxel and
      polyglutamate paclitaxel may also stop the growth of ovarian epithelial or peritoneal cancer
      by blocking blood flow to the tumor. Sometimes, after treatment, the tumor may not need
      additional treatment until it progresses. In this case, observation may be sufficient. It is
      not yet known whether paclitaxel is more effective than polyglutamate paclitaxel or
      observation only in treating ovarian epithelial, peritoneal, or fallopian tube cancer.
    

Detailed Description

      PRIMARY OBJECTIVES:

      I. To determine whether CT-2103 (polyglutamate paclitaxel) or paclitaxel, administered to
      women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a
      clinically-defined complete response to primary platinum/taxane-based chemotherapy
      ("consolidation/maintenance therapy") will reduce the death rate, compared to re-treatment at
      the time of documented disease progression.

      II. To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity
      profile (with a particular focus on peripheral neuropathy as measured by the Gynecologic
      Oncology Group [GOG] NTX4) and superior quality-of-life (as measured by the Functional
      Assessment of Cancer Therapy-Ovarian [FACT-O]), compared to paclitaxel.

      SECONDARY OBJECTIVES:

      I. To explore the relationship between expression of several of the angiogenic markers and
      overall survival or progression-free survival in patients randomized to CT-2103, paclitaxel,
      or no treatment.

      II. To assess the association among the various tissue and serum markers of angiogenesis, and
      compare the ability of different combinations of these markers to predict patient outcome
      including overall survival and progression-free survival in patients randomized to CT-2103,
      paclitaxel, or no treatment.

      III. To bank deoxyribonucleic acid (DNA) from whole blood for research and evaluate the
      association between single nucleotide polymorphisms (SNPs) and measures of clinical outcome
      including overall survival, progression-free survival and adverse events.

      OUTLINE: Patients are randomized to 1 of 3 treatment arms.

      ARM I: Patients receive polyglutamate paclitaxel intravenously (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
      progression.

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

      After completion of study treatment, patients are followed every 3 months for 2 years and
      then every 6 months for 10 years.
    

Study Phase

Phase 3

Study Type

Interventional


Primary Outcome

Overall Survival

Secondary Outcome

 Progression-free Survival

Condition

Fallopian Tube Clear Cell Adenocarcinoma

Intervention

Clinical Observation

Study Arms / Comparison Groups

 Arm I (paclitaxel poliglumex)
Description:  Patients receive polyglutamate paclitaxel IV over 10-20 minutes on day 1.Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

1157

Start Date

March 21, 2005

Completion Date

February 22, 2022

Primary Completion Date

February 3, 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Patients with a histologic diagnosis of primary peritoneal carcinoma, or stage III or
             IV epithelial ovarian or fallopian tube carcinoma, with either optimal (=< 1 cm
             residual disease) or suboptimal residual disease following initial surgery; all
             patients must have had appropriate surgery for ovarian, primary peritoneal or
             fallopian tube carcinoma with appropriate tissue available for histologic evaluation
             to confirm diagnosis and stage

          -  Patients with the following histologic epithelial cell types are eligible:

               -  Serous adenocarcinoma

               -  Endometrioid adenocarcinoma

               -  Mucinous adenocarcinoma

               -  Undifferentiated carcinoma

               -  Clear cell adenocarcinoma

               -  Mixed epithelial carcinoma

               -  Transitional cell carcinoma

               -  Malignant Brenner tumor

               -  Adenocarcinoma not otherwise specified (NOS)

          -  Patients must have completed treatment within the past 12 weeks with at least 5 cycles
             and not more than 8 cycles of a platinum (IV or intraperitoneal [IP]) and paclitaxel
             or docetaxel-based combination chemotherapy and have no symptoms suggestive of
             persistent cancer, normal (no evidence of cancer) computed tomography (CT) scan of the
             abdomen/pelvis and normal cancer antigen 125 (CA-125) following this therapy

               -  Patients treated with neo-adjuvant platinum-taxane chemotherapy for a presumptive
                  diagnosis of stage III or IV epithelial ovarian, primary peritoneal or, fallopian
                  tube (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided
                  that they have undergone interval abdominal surgery after at least one but no
                  more than six cycles of standard chemotherapy; such surgery must meet the same
                  criteria as for those undergoing up front surgery, including tissue diagnosis for
                  confirmation of primary tumor site and stage III or IV disease; also, patients
                  must have received at least two cycles after interval abdominal surgery

          -  Absolute neutrophil count >= 1,500/ul, equivalent to Common Toxicity Criteria (CTCAE
             version [v]3.0) grade 1

          -  Platelet count >= 100,000/ul

          -  Creatinine =< 1.5 times institutional upper limit of normal (ULN), CTCAE v3.0 grade 1

          -  Bilirubin =< 1.5 times ULN, (CTCAE v3.0 grade 1)

          -  Serum glutamic oxaloacetic transaminase (SGOT) =< 2.5 times ULN (CTCAE v3.0 grade 1)

          -  Alkaline phosphatase =< 2.5 times ULN (CTCAE v3.0 grade 1)

          -  Neuropathy (sensory and motor) less than or equal to CTCAE v3.0 grade 1

          -  Gynecologic Oncology Group (GOG) performance status of 0, 1, or 2

          -  Patients must have signed an approved informed consent and Health Insurance
             Portability and Accountability Act (HIPAA) authorization

          -  Patients must complete pre-entry assessments

        Exclusion Criteria:

          -  Patients with a current diagnosis of epithelial ovarian or fallopian tube tumor of low
             malignant potential (LMP) (Borderline carcinomas) are not eligible; patients with a
             prior diagnosis of a low malignant potential tumor that was surgically resected and
             who subsequently develop invasive adenocarcinoma are eligible, provided that they have
             not received prior chemotherapy for their ovarian LMP tumor

          -  Germ cell tumors, sex cord-stromal tumors, carcinosarcomas, mixed mullerian tumors or
             carcinosarcomas, metastatic carcinomas from other sites to the ovary and low malignant
             potential tumors including so called micropapillary serous carcinomas are not eligible

          -  Patients who have received prior radiotherapy to any portion of the abdominal cavity
             or pelvis are excluded; prior radiation for localized cancer of the breast, head and
             neck, or skin is permitted, provided that it was completed more than 3 years prior to
             registration, and the patient remains free of recurrent or metastatic disease

          -  Patients who have received investigational therapies, and/or biological therapies
             (i.e. Bevacizumab or Erlotinib) for their epithelial ovarian, primary peritoneal or
             fallopian tube cancers or for any other abdominal or pelvic tumor, are not excluded;
             however, biologics cannot be continued concurrent with the GOG-012 maintenance
             treatment (or observation); patients who have received prior chemotherapy for any
             other abdominal or pelvic tumor (except as noted above) are excluded; patients may
             have received prior adjuvant chemotherapy for localized breast cancer, provided that
             it was completed more than 3 years prior to registration, and that the patient remains
             free of recurrent or metastatic disease

          -  Patients with synchronous primary endometrial cancer, or a past history of primary
             endometrial cancer, are excluded, unless all of the following conditions are met:

               -  Stage not greater than I-B

               -  Less than 3 mm invasion without vascular or lymphatic invasion

               -  No poorly differentiated subtypes, including papillary serous, clear cell, or
                  other Federation of Gynecology and Obstetrics (FIGO) Grade 3 lesions

          -  With the exception of non-melanoma skin cancer and other specific malignancies as
             noted above, patients with other invasive malignancies who had (or have) any evidence
             of the other cancer present within the last 5 years or whose previous cancer treatment
             contraindicates this protocol therapy are excluded

          -  Patients with acute hepatitis, or known chronic hepatitis

          -  Patients with an active infection that requires antibiotics

          -  Patients with ongoing gastrointestinal bleeding requiring blood product support

          -  Patients whose circumstances at the time of entry onto the protocol would not permit
             completion of study or required follow up

          -  Patients with unstable angina or those who have had a myocardial infarction within the
             past six months; patients with evidence of abnormal cardiac conduction (e.g. bundle
             branch block, heart block) are eligible if their disease has been stable for the past
             six months

          -  Patients are excluded who have had prior therapy with CT-2103

          -  Patients with active bleeding or an unexplained prothrombin time (PT) or partial
             thromboplastin time (PTT) > institutional upper limit normal (ULN)

          -  Patients who are pregnant or nursing are excluded; patients who may become pregnant
             must practice an effective method of birth control
      

Gender

Female

Ages

N/A - N/A

Accepts Healthy Volunteers

No

Contacts

Larry J Copeland, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00108745

Organization ID

GOG-0212

Secondary IDs

NCI-2009-00586

Responsible Party

Sponsor

Study Sponsor

GOG Foundation

Collaborators

 National Cancer Institute (NCI)

Study Sponsor

Larry J Copeland, Principal Investigator, NRG Oncology


Verification Date

March 2021