MDACC Study Summary GOG 0212

Study Summary
No. GOG 0212:.......Ovary; Peritoneum......Robert Coleman......Gynecologic Oncology

Study Summary Title



Study Summary Number:	GOG 0212

Study Title:	A Randomized Phase III Trial of Maintenance Chemotherapy Comparing 12 Monthly Cycles of Single Agent Paclitaxel or CT-2103 (IND# 70177), 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

Physician

New Patient Referral



Name:	Robert Coleman	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Gynecologic Oncology	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-3357 Contact us about clinical trials

General Information



Disease Group:	Ovary Peritoneum	Supported By:	Cell Therapeutics, Inc. Gynecologic Oncology Group (GOG)

Phase of Study:	Phase III	Return Visit:	REGIMEN I: every 28 days x 12 for treatment REGIMEN II: every 28 days x 12 for treatment REGIMEN III: patients will be followed until disease progression, unacceptable toxicity or completion of the planned treatment program for up to 5 years.

Treatment Agents:	CT-2103 None Paclitaxel	Home Care:	None

Treatment Loc:	Both at MDACC & outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	N/A

Description/
Intervention:

The goal of this clinical research study is to compare treatment with
paclitaxel or CT-2103 to no treatment at all in women with advanced ovarian,
primary peritoneal or fallopian tube cancer who have no evidence of disease
after the completion of their first round of chemotherapy. Researchers want to
find out if these women stay in remission longer and have a better survival
rate when they receive chemotherapy, once a month for 12 months, versus
stopping all chemotherapy until there is evidence that the disease has
returned.

Study Objectives / Outcomes

Clinical Objectives:
1. To determine whether CT-2103 or paclitaxel, administered to women with advanced ovarian cancer, 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.
2. 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 GOG NTX4) and superior quality of life (as measured by the FACT-O) compared to paclitaxel.

Translational Research Objectives:
The overall goal of the translational research component of this protocol is to assess the clinical relevance of markers of angiogenesis in patients with advanced ovarian, primary peritoneal and fallopian tube cancer who achieve a clinically-defined complete response to primary platinum/taxane-based chemotherapy and are randomized to CT-2103, paclitaxel, or no treatment until the time of documented disease progression.
1. 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.
2. 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.

Study Status Information



Study Activation / Registration Date:	08/03/2005

IRB Review and Approval Date:	06/15/2005

Study Type:	Therapeutic

Recruitment Status:	Open

Projected Accrual:	1100 eligible participants

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 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.

2) 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's Tumor, or adenocarcinoma N.O.S.

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

4) Pts treated with neo-adjuvant platinum-taxane chemotx for a presumptive diagnosis of stage III or IV PPC or EOC (by paracentesis, percutaneous biopsy or open biopsy) are eligible provided that they have undergone interval abdominal surgery after at least 1 but no more than 6 cycles of standard chemotx as defined in # 3 above. 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.

5) Patients must have adequate: BONE MARROW FUNCTION: Absolute neutrophil count (ANC) > than or = to 1,500/mcg, equivalent to Common Toxicity Criteria (CTCAE) v 3.0, grade 1. Platelets > or = to 100,000/mcg. RENAL FUNCTION: Creatinine < or = to 1.5 x institutional upper limit normal (ULN), CTCAE v 3.0, grade 1. HEPATIC FUNCTION: Bilirubin < than or = to 1.5 x ULN (CTCAE 3.0, grade 1). SGOT and alkaline phosphatase < or = to 2.5 x ULN (CTCAE 3.0, grade 1). NEUROLOGIC FUNCTION: Neuropathy (sensory and motor) < or = to CTCAE 3.0, grade 1.

6) Patients must have a GOG Performance Status of 0, 1, or 2.

7) Patients must have signed an approved informed consent and HIPAA authorization.

8) Patients must complete pre-entry assessments: History and physical exam, CBC and differential, platelets, serum creatinine, bilirubin, SGOT, alkaline phosphatase, CA-125, chest x-ray, EKG, urinalysis, coagulation profile (PT, PTT, INR), CT scan of abdomen/pelvis.

Exclusion Criteria:

1) 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 LMP tumor that was surgically resected and who subsequently develop invasive adenocarcinoma are eligible, provided that they have not received prior chemotherapy for the ovarian LMP tumor.

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

3) 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.

4) Patients who have received prior chemotherapy, investigational therapies, and/or biological therapies (i.e. Bevacizamab or Erlotinib) for any other abdominal or pelvic tumor (except as noted above) 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.

5) 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 3mm invasion without vascular or lymphatic invasion; No poorly differentiated subtypes, including papillary serous, clear cell, or other FIGO Grade 3 lesions.

6) 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.

7) Patients with acute hepatitis, or known chronic hepatitis.

8) Patients with an active infection that requires antibiotics.

9) Patients with ongoing gastrointestinal bleeding requiring blood product support.

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

11) 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.

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

13) Patients with active bleeding or an unexplained PT or PTT > institutional upper limit normal (ULN).

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

Links

Registration Number: NCT00108745
Study Information on Clinical Trials Registry (clinicaltrials.gov)